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Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia (CIDAR-3)

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ClinicalTrials.gov Identifier: NCT01012167
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
William Carpenter, University of Maryland

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Oxytocin
Drug: Galantamine
Other: Placebo-Oxytocin
Other: Placebo-Galantamine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Consented/Screened for Study-- N=86

Withdrew prior to randomization (N=28)

  • 2 withdrew consent
  • 26 did not meet inclusion criteria

Randomized-- N=58


Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Participant Flow:   Overall Study
    1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin
STARTED   17   20   21 
Withdrawn Prior to Study Drug Exposure   1   0   1 
Exposed to Study Drug   16   20   20 
COMPLETED   15   18   17 
NOT COMPLETED   2   2   4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Number of participants randomized N=58

Withdrawn prior to exposure to study drug (N=2) Oxytocin N=1 withdrawn due to abnormal EKG Placebo N=1 Participant withdrew consent

Exposed to study drug N=56


Reporting Groups
  Description
1: Oxytocin Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
2: Galantamine Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
3: Placebo Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
Total Total of all reporting groups

Baseline Measures
   1: Oxytocin   2: Galantamine   3: Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   20   20   56 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      16 100.0%      20 100.0%      20 100.0%      56 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.4  (11.2)   45.8  (12.4)   42.2  (11.7)   44.9  (11.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      2  12.5%      6  30.0%      3  15.0%      11  19.6% 
Male      14  87.5%      14  70.0%      17  85.0%      45  80.4% 
Region of Enrollment 
[Units: Participants]
       
United States   16   20   20   56 


  Outcome Measures

1.  Primary:   Scale for the Assessment of Negative Symptoms (SANS) Total Score   [ Time Frame: Every other week for 6 weeks ]

Measure Type Primary
Measure Title Scale for the Assessment of Negative Symptoms (SANS) Total Score
Measure Description Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.
Time Frame Every other week for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   19   19 
Scale for the Assessment of Negative Symptoms (SANS) Total Score 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   15   19   19 
Treatment Week 0   33.23  (6.91)   36.63  (10.09)   36.63  (10.61) 
Treatment Week 2       
Participants Analyzed   15   19   19 
Treatment Week 2   30.07  (6.93)   35.22  (10.97)   35.05  (10.52) 
Treatment Week 4       
Participants Analyzed   15   18   18 
Treatment Week 4   31.27  (7.53)   34.06  (10.26)   34.22  (9.61) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   31.40  (6.85)   33.22  (10.64)   33.47  (8.47) 
Change from Week 0 at Week 2       
Participants Analyzed   15   19   19 
Change from Week 0 at Week 2   -3.17  (4.20)   -1.41  (3.32)   -1.58  (4.84) 
Change from Week 0 at Week 4       
Participants Analyzed   15   18   18 
Change from Week 0 at Week 4   -1.97  (4.48)   -1.69  (3.46)   -1.47  (5.64) 
Change from Week 0 at Week 6       
Participants Analyzed   15   18   17 
Change from Week 0 at Week 6   -1.83  (3.74)   -2.53  (4.34)   -1.00  (4.41) 

No statistical analysis provided for Scale for the Assessment of Negative Symptoms (SANS) Total Score



2.  Primary:   Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week   [ Time Frame: Treatment Week 0 and Week 6 ]

Measure Type Primary
Measure Title Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week
Measure Description * Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome.
Time Frame Treatment Week 0 and Week 6  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Five subjects were unable to handle the demands of the Rapid Visual Information Processing (RVIP) test, part of the composite primary outcome measure, and did not provide valid data.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   14   15   16 
Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   14   15   16 
Treatment Week 0   0.23  (0.92)   -0.22  (0.47)   0.21  (0.83) 
Treatment Week 6       
Participants Analyzed   14   15   15 
Treatment Week 6   0.33  (1)   -0.05  (0.68)   0.18  (0.69) 
Change       
Participants Analyzed   14   15   15 
Change   0.1  (0.37)   0.17  (0.44)   0.03  (0.41) 

No statistical analysis provided for Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week



3.  Secondary:   Scale for the Assessment of Negative Symptoms (SANS) - Avolition   [ Time Frame: Every other week for 6 weeks ]

Measure Type Secondary
Measure Title Scale for the Assessment of Negative Symptoms (SANS) - Avolition
Measure Description Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Time Frame Every other week for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   19   19 
Scale for the Assessment of Negative Symptoms (SANS) - Avolition 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   15   19   19 
Treatment Week 0   2.94  (0.90)   2.91  (0.88)   2.44  (0.97) 
Treatment Week 2       
Participants Analyzed   15   19   19 
Treatment Week 2   2.78  (0.77)   2.73  (0.74)   2.43  (0.93) 
Treatment Week 4       
Participants Analyzed   15   18   18 
Treatment Week 4   2.85  (1.04)   2.74  (.084)   2.44  (0.94) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   2.88  (0.89)   2.74  (0.90)   2.41  (0.87) 
Change from Week 0 at Week 2       
Participants Analyzed   15   19   19 
Change from Week 0 at Week 2   -0.15  (0.32)   -0.18  (0.43)   -0.01  (0.57) 
Change from Week 0 at Week 4       
Participants Analyzed   15   18   18 
Change from Week 0 at Week 4   -0.09  (0.31)   -0.16  (0.50)   0.04  (0.43) 
Change from Week 0 at Week 6       
Participants Analyzed   15   18   17 
Change from Week 0 at Week 6   -0.05  (0.48)   -0.16  (0.69)   0.05  (0.46) 

No statistical analysis provided for Scale for the Assessment of Negative Symptoms (SANS) - Avolition



4.  Secondary:   Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia   [ Time Frame: Every other week for 6 weeks ]

Measure Type Secondary
Measure Title Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia
Measure Description Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Time Frame Every other week for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   19   19 
Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   15   19   19 
Treatment Week 0   2.42  (0.59)   2.60  (0.80)   2.66  (0.69) 
Treatment Week 2       
Participants Analyzed   15   19   19 
Treatment Week 2   2.42  (0.64)   2.59  (0.86)   2.58  (0.66) 
Treatment Week 4       
Participants Analyzed   15   18   18 
Treatment Week 4   2.27  (0.78)   2.46  (0.99)   2.60  (0.64) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   2.33  (0.49)   2.43  (0.98)   2.66  (0.60) 
Change from Week 0 at Week 2       
Participants Analyzed   15   19   19 
Change from Week 0 at Week 2   0.00  (0.37)   -0.01  (0.40)   -0.08  (0.51) 
Change from Week 0 at Week 4       
Participants Analyzed   15   18   18 
Change from Week 0 at Week 4   -0.15  (0.68)   -0.11  (.013)   0.01  (0.50) 
Change from Week 0 at Week 6       
Participants Analyzed   15   18   17 
Change from Week 0 at Week 6   -0.09  (0.38)   -0.14  (0.38)   0.12  (0.47) 

No statistical analysis provided for Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia



5.  Secondary:   Scale for the Assessment of Negative Symptoms (SANS) - Alogia   [ Time Frame: Every other week for 6 weeks ]

Measure Type Secondary
Measure Title Scale for the Assessment of Negative Symptoms (SANS) - Alogia
Measure Description Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Time Frame Every other week for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   19   19 
Scale for the Assessment of Negative Symptoms (SANS) - Alogia 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   15   19   19 
Treatment Week 0   0.60  (0.61)   0.95  (0.65)   0.99  (0.69) 
Treatment Week 2       
Participants Analyzed   15   19   19 
Treatment Week 2   0.44  (0.67)   0.89  (0.59)   0.89  (0.80) 
Treatment Week 4       
Participants Analyzed   15   18   18 
Treatment Week 4   0.56  (0.70)   0.85  (0.50)   0.80  (0.61) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   0.56  (0.69)   0.78  (0.44)   0.69  (0.57) 
Change from Week 0 at Week 2       
Participants Analyzed   15   19   19 
Change from Week 0 at Week 2   -0.16  (0.42)   -0.05  (0.36)   -0.10  (0.35) 
Change from Week 0 at Week 4       
Participants Analyzed   15   18   18 
Change from Week 0 at Week 4   -0.04  (0.41)   -0.03  (0.37)   -0.17  (0.31) 
Change from Week 0 at Week 6       
Participants Analyzed   15   18   17 
Change from Week 0 at Week 6   -0.04  (0.46)   -0.10  (0.31)   -0.19  (0.31) 

No statistical analysis provided for Scale for the Assessment of Negative Symptoms (SANS) - Alogia



6.  Secondary:   Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect   [ Time Frame: Every other week for 6 weeks ]

Measure Type Secondary
Measure Title Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect
Measure Description Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.
Time Frame Every other week for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   19   19 
Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   15   19   19 
Treatment Week 0   1.67  (0.86)   1.96  (1.06)   2.21  (0.97) 
Treatment Week 2       
Participants Analyzed   15   19   19 
Treatment Week 2   1.32  (0.90)   1.89  (1.10)   2.05  (1.12) 
Treatment Week 4       
Participants Analyzed   15   18   18 
Treatment Week 4   1.52  (0.91)   1.79  (0.99)   1.94  (0.98) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   1.48  (0.96)   1.70  (1.05)   1.85  (0.94) 
Change from Week 0 at Week 2       
Participants Analyzed   15   19   19 
Change from Week 0 at Week 2   -0.35  (0.36)   -0.07  (0.36)   -0.16  (0.47) 
Change from Week 0 at Week 4       
Participants Analyzed   15   18   18 
Change from Week 0 at Week 4   -0.15  (0.44)   -0.09  (0.33)   -0.19  (0.60) 
Change from Week 0 at Week 6       
Participants Analyzed   15   18   17 
Change from Week 0 at Week 6   -0.19  (0.36)   -0.17  (0.40)   -0.19  (0.38) 

No statistical analysis provided for Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect



7.  Secondary:   Brief Psychiatric Rating Scale (BPRS) - Total Score   [ Time Frame: Every other week for 6 weeks ]

Measure Type Secondary
Measure Title Brief Psychiatric Rating Scale (BPRS) - Total Score
Measure Description The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
Time Frame Every other week for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data available for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   16   20   20 
Brief Psychiatric Rating Scale (BPRS) - Total Score 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   16   20   20 
Treatment Week 0   34.16  (5.66)   30.35  (6.66)   32.65  (7.09) 
Treatment Week 2       
Participants Analyzed   15   19   20 
Treatment Week 2   34.00  (7.46)   28.95  (7.83)   31.75  (7.26) 
Treatment Week 4       
Participants Analyzed   15   18   18 
Treatment Week 4   34.07  (6.15)   27.83  (6.88)   31.72  (7.25) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   34.33  (5.09)   27.67  (6.42)   32.18  (6.21) 

No statistical analysis provided for Brief Psychiatric Rating Scale (BPRS) - Total Score



8.  Secondary:   Brief Psychiatric Rating Scale (BPRS) - Psychosis Score   [ Time Frame: Every other week for 6 weeks ]

Measure Type Secondary
Measure Title Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Measure Description The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.
Time Frame Every other week for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data available for the 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
2: Galantamine Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
3: Placebo Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Brief Psychiatric Rating Scale (BPRS) - Psychosis Score 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   16   20   20 
Treatment Week 0   9.34  (3.20)   7.30  (3.01)   8.18  (3.80) 
Treatment Week 2       
Participants Analyzed   15   19   20 
Treatment Week 2   9.40  (3.79)   7.21  (3.61)   7.90  (3.86) 
Treatment Week 4       
Participants Analyzed   15   18   18 
Treatment Week 4   9.87  (3.60)   7.00  (3.48)   8.06  (4.09) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   9.67  (2.87)   6.78  (3.21)   7.59  (4.35) 

No statistical analysis provided for Brief Psychiatric Rating Scale (BPRS) - Psychosis Score



9.  Secondary:   Calgary Depression Scale (CDS) - Total Score   [ Time Frame: Every other week for 6 weeks ]

Measure Type Secondary
Measure Title Calgary Depression Scale (CDS) - Total Score
Measure Description Total score calculated by adding scores for scales #1-#9. Each scale ranges from "0=Absent" to "3=Severe". The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating.
Time Frame Every other week for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   19   19 
Calgary Depression Scale (CDS) - Total Score 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   15   19   19 
Treatment Week 0   2.37  (2.70)   0.84  (1.07)   1.59  (1.54) 
Treatment Week 2       
Participants Analyzed   15   19   19 
Treatment Week 2   2.20  (2.54)   1.05  (1.65)   1.00  (1.29) 
Treatment Week 4       
Participants Analyzed   15   18   18 
Treatment Week 4   2.13  (2.13)   0.67  (1.28)   0.94  (1.97) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   1.67  (2.47)   0.50  (0.71)   1.29  (1.45) 

No statistical analysis provided for Calgary Depression Scale (CDS) - Total Score



10.  Secondary:   Arizona Sexual Experience Questionnaire (ASEX) Female   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Arizona Sexual Experience Questionnaire (ASEX) Female
Measure Description Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Female participants who completed at least two weeks follow-up.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   2   6   3 
Arizona Sexual Experience Questionnaire (ASEX) Female 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   2   6   3 
Treatment Week 0   10.5  (0.7)   21.2  (7.6)   29.0  (1.7) 
Treatment Week 6       
Participants Analyzed   2   6   2 
Treatment Week 6   13.5  (0.7)   19.2  (9.3)   30.0  (0) 
Change       
Participants Analyzed   2   6   2 
Change   3.0  (0.0)   -2.0  (3.5)   0.0  (0.0) 

No statistical analysis provided for Arizona Sexual Experience Questionnaire (ASEX) Female



11.  Secondary:   Arizona Sexual Experience Questionnaire (ASEX) Male   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Arizona Sexual Experience Questionnaire (ASEX) Male
Measure Description Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Male participants who completed at least two weeks follow-up.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   14   14   16 
Arizona Sexual Experience Questionnaire (ASEX) Male 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   13   14   16 
Treatment Week 0   16.5  (9.2)   18.1  (6.7)   20.8  (6.3) 
Treatment Week 6       
Participants Analyzed   14   12   13 
Treatment Week 6   17.1  (8.5)   20.2  (7.5)   21.7  (7.7) 
Change       
Participants Analyzed   14   12   12 
Change   1.5  (7.8)   1.6  (5.0)   0.8  (6.2) 

No statistical analysis provided for Arizona Sexual Experience Questionnaire (ASEX) Male



12.  Secondary:   Vital Signs - Diastolic Blood Pressure   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Vital Signs - Diastolic Blood Pressure
Measure Description Mean diastolic blood pressure by treatment and follow-up week
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   16   20   20 
Vital Signs - Diastolic Blood Pressure 
[Units: mm-Hg]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   16   20   20 
Treatment Week 0   78.8  (8.3)   76.6  (10.7)   78.3  (10.1) 
Treatment Week 1       
Participants Analyzed   15   19   19 
Treatment Week 1   78.4  (9.0)   76.2  (8.9)   75.5  (10.8) 
Treatment Week 2       
Participants Analyzed   15   19   19 
Treatment Week 2   76.7  (9.1)   77.5  (8.4)   79.7  (10.6) 
Treatment Week 3       
Participants Analyzed   15   16   19 
Treatment Week 3   75.0  (10.6)   79.1  (6.9)   78.9  (8.1) 
Treatment Week 4       
Participants Analyzed   15   18   18 
Treatment Week 4   73.9  (8.2)   75.1  (7.3)   73.7  (9.7) 
Treatment Week 5       
Participants Analyzed   15   16   17 
Treatment Week 5   76.2  (8.8)   79.2  (8.4)   77.2  (10.9) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   74.4  (8.3)   80.7  (6.9)   76.0  (9.9) 

No statistical analysis provided for Vital Signs - Diastolic Blood Pressure



13.  Secondary:   Vital Signs - Systolic Blood Pressure   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Vital Signs - Systolic Blood Pressure
Measure Description Mean systolic blood pressure by treatment and follow-up week
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   16   20   20 
Vital Signs - Systolic Blood Pressure 
[Units: mm-Hg]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   16   20   20 
Treatment Week 0   128.4  (16.7)   123.4  (17.3)   132.3  (19.6) 
Treatment Week 1       
Participants Analyzed   15   19   19 
Treatment Week 1   126.1  (16.9)   123.9  (15.0)   127.4  (22.1) 
Treatment Week 2       
Participants Analyzed   15   19   19 
Treatment Week 2   121.9  (20.5)   123.7  (13.8)   136.2  (25.1) 
Treatment Week 3       
Participants Analyzed   15   16   19 
Treatment Week 3   129.5  (21.1)   127.3  (19.0)   137.7  (17.0) 
Treatment Week 4       
Participants Analyzed   15   18   18 
Treatment Week 4   124.8  (17.3)   123.8  (19.0)   129.9  (16.5) 
Treatment Week 5       
Participants Analyzed   15   16   17 
Treatment Week 5   128.4  (20.5)   126.9  (20.1)   132.8  (19.5) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   124.0  (17.5)   129.6  (16.1)   134.5  (19.4) 

No statistical analysis provided for Vital Signs - Systolic Blood Pressure



14.  Secondary:   Vital Signs - Weight   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Vital Signs - Weight
Measure Description Mean weight (kg) by treatment and follow-up week
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   16   20   20 
Vital Signs - Weight 
[Units: Kg]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   16   20   20 
Treatment Week 0   96.5  (18.4)   96.2  (16.2)   96.4  (20.0) 
Treatment Week 1       
Participants Analyzed   15   19   18 
Treatment Week 1   97.8  (19.1)   97.5  (16.0)   97.9  (18.9) 
Treatment Week 2       
Participants Analyzed   15   19   19 
Treatment Week 2   98.0  (18.9)   97.5  (16.1)   98.3  (18.8) 
Treatment Week 3       
Participants Analyzed   15   16   19 
Treatment Week 3   98.0  (18.9)   94.5  (13.8)   98.4  (19.5) 
Treatment Week 4       
Participants Analyzed   14   18   18 
Treatment Week 4   100.0  (17.9)   95.5  (14.4)   100.3  (17.7) 
Treatment Week 5       
Participants Analyzed   15   16   17 
Treatment Week 5   98.1  (18.6)   94.0  (14.6)   100.8  (17.7) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   97.6  (18.0)   95.1  (14.7)   97.9  (16.3) 

No statistical analysis provided for Vital Signs - Weight



15.  Secondary:   Vital Signs - Pulse   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Vital Signs - Pulse
Measure Description Mean sitting pulse (bpm) by treatment and follow-up week
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   16   20   20 
Vital Signs - Pulse 
[Units: Bpm]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   16   20   20 
Treatment Week 0   81.2  (10.4)   86.0  (14.1)   85.2  (13.4) 
Treatment Week 1       
Participants Analyzed   15   19   19 
Treatment Week 1   86.2  (18.8)   91.6  (14.9)   89.3  (16.7) 
Treatment Week 2       
Participants Analyzed   15   19   19 
Treatment Week 2   82.7  (17.3)   91.3  (14.2)   87.3  (15.3) 
Treatment Week 3       
Participants Analyzed   15   16   19 
Treatment Week 3   76.5  (11.5)   89.2  (15.6)   89.2  (13.8) 
Treatment Week 4       
Participants Analyzed   15   18   18 
Treatment Week 4   79.6  (13.2)   88.6  (12.9)   83.7  (14.2) 
Treatment Week 5       
Participants Analyzed   15   16   17 
Treatment Week 5   78.4  (13.2)   98.6  (28.1)   90.5  (16.0) 
Treatment Week 6       
Participants Analyzed   15   18   17 
Treatment Week 6   76.1  (15.0)   85.2  (16.6)   84.7  (12.2) 

No statistical analysis provided for Vital Signs - Pulse



16.  Secondary:   Simpson-Angus Scale (SAS)   [ Time Frame: Baseline, week 3, and week 6 ]

Measure Type Secondary
Measure Title Simpson-Angus Scale (SAS)
Measure Description SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from "0=None/Normal" to "4=Extreme/Severe". The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating.
Time Frame Baseline, week 3, and week 6  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   19   19 
Simpson-Angus Scale (SAS) 
[Units: Percentage of participants]
     
No worsening (0)   80   63.16   78.95 
Worsening of 1   16.67   10.53   10.53 
Worsening of 2   6.67   15.79   0 
Worsening of 3   6.67   5.26   5.26 
Worsening of 4   0   5.26   0 
Worsening of 10   0   0   5.26 

No statistical analysis provided for Simpson-Angus Scale (SAS)



17.  Secondary:   Abnormal Involuntary Movement Scale (AIMS)   [ Time Frame: Treatment Week 0 and Week 6 ]

Measure Type Secondary
Measure Title Abnormal Involuntary Movement Scale (AIMS)
Measure Description AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from "0=None" to "4=Severe". The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating.
Time Frame Treatment Week 0 and Week 6  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
50 participants who completed the trial.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   18   17 
Abnormal Involuntary Movement Scale (AIMS) 
[Units: Percentage of participants]
     
No worsening (0)   86.67   77.78   76.47 
Worsening of 1   6.67   16.67   17.65 
Worsening of 2   6.67   0   0 
Worsening of 3   0   0   5.88 
Worsening of 5   0   5.56   0 

No statistical analysis provided for Abnormal Involuntary Movement Scale (AIMS)



18.  Secondary:   Electrocardiogram (EKG)   [ Time Frame: Once during Evaluation and once at Treatment Week 6 ]

Measure Type Secondary
Measure Title Electrocardiogram (EKG)
Measure Description Mean corrected QT interval (QTc) by study week and treatment.
Time Frame Once during Evaluation and once at Treatment Week 6  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
50 participants who completed the trial.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   18   17 
Electrocardiogram (EKG) 
[Units: QTc]
Mean (Standard Deviation)
     
Evaluation Week 0       
Participants Analyzed   14   17   17 
Evaluation Week 0   416.5  (23.1)   419.0  (26.6)   422.6  (25.5) 
Treatment Week 6       
Participants Analyzed   15   18   16 
Treatment Week 6   415.7  (28.3)   408.1  (27.2)   423.8  (26.7) 
Change       
Participants Analyzed   14   17   16 
Change   -2.9  (20.7)   -10.2  (18.3)   0.9  (20.3) 

No statistical analysis provided for Electrocardiogram (EKG)



19.  Secondary:   Barnes Akathisia Scale (BAS) - Global Score   [ Time Frame: Treatment Week 0 and Week 6 ]

Measure Type Secondary
Measure Title Barnes Akathisia Scale (BAS) - Global Score
Measure Description For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from "0=Absent" to "5=Severe Akathisia". Higher scores indicate a more severe global rating of akathisia.
Time Frame Treatment Week 0 and Week 6  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
50 participants who completed the trial.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   18   17 
Barnes Akathisia Scale (BAS) - Global Score 
[Units: Percentage of participants]
     
No worsening (0)   93.33   100   94.12 
Worsening of 1   6.67   0   5.88 

No statistical analysis provided for Barnes Akathisia Scale (BAS) - Global Score



20.  Secondary:   Blood Oxytocin Levels   [ Time Frame: Treatment Week 0 and Week 6 ]

Measure Type Secondary
Measure Title Blood Oxytocin Levels
Measure Description Blood Oxytocin Levels by Treatment and Visit
Time Frame Treatment Week 0 and Week 6  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin.

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   16   20   17 
Blood Oxytocin Levels 
[Units: pg/mL]
Mean (Standard Deviation)
     
Treatment Week 0       
Participants Analyzed   16   20   17 
Treatment Week 0   18.22  (15.52)   13.76  (6.96)   14.69  (7.99) 
Treatment Week 6       
Participants Analyzed   14   15   13 
Treatment Week 6   17.22  (17.02)   10.11  (3.42)   13.21  (9.32) 
Change       
Participants Analyzed   14   15   11 
Change   -1.88  (14.09)   -2.99  (5.2)   -1.73  (3.95) 

No statistical analysis provided for Blood Oxytocin Levels



21.  Secondary:   Laboratory Measures - ALT/SGPT   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - ALT/SGPT
Measure Description Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data at Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   20   20 
Laboratory Measures - ALT/SGPT 
[Units: U/L]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   20 
Evaluation   22.87  (8.68)   31.26  (22.93)   27.40  (19.78) 
Treatment Week 6       
Participants Analyzed   15   20   19 
Treatment Week 6   20.67  (13.03)   28.90  (22.81)   27.74  (16.62) 
Change       
Participants Analyzed   13   17   16 
Change   -2.15  (10.20)   -2.65  (6.14)   0.31  (8.10) 

No statistical analysis provided for Laboratory Measures - ALT/SGPT



22.  Secondary:   Laboratory Measures - AST/SGOT   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - AST/SGOT
Measure Description Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data at Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   20   20 
Laboratory Measures - AST/SGOT 
[Units: U/L]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   20 
Evaluation   19.87  (5.46)   22.68  (9.68)   22.50  (9.29) 
Treatment Week 6       
Participants Analyzed   15   20   19 
Treatment Week 6   20.27  (8.94)   21.45  (10.16)   23.58  (9.26) 
Change       
Participants Analyzed   13   17   16 
Change   -1.46  (4.20)   -1.53  (8.13)   1.00  (5.43) 

No statistical analysis provided for Laboratory Measures - AST/SGOT



23.  Secondary:   Laboratory Measures - Alkaline Phosphatase   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Alkaline Phosphatase
Measure Description Alkaline phosphatase blood level by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data at Evaluation at Week 6.

Reporting Groups
  Description
1: Oxytocin/Placebo-galantamine Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine/Placebo-oxytocin Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo-galantamine /Placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin/Placebo-galantamine   2: Galantamine/Placebo-oxytocin   3: Placebo-galantamine /Placebo-oxytocin 
Participants Analyzed   15   20   20 
Laboratory Measures - Alkaline Phosphatase 
[Units: U/L]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   20 
Evaluation   83.47  (21.56)   83.42  (16.29)   86.40  (23.37) 
Treatment Week 6       
Participants Analyzed   15   20   19 
Treatment Week 6   78.73  (31.09)   82.50  (20.50)   88.95  (29.67) 
Change       
Participants Analyzed   13   17   16 
Change   -4.77  (15.81)   0.88  (10.29)   1.19  (10.97) 

No statistical analysis provided for Laboratory Measures - Alkaline Phosphatase



24.  Secondary:   Laboratory Measures - Calcium   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Calcium
Measure Description Calcium blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data at Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   20   20 
Laboratory Measures - Calcium 
[Units: mg/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   20 
Evaluation   9.53  (0.33)   9.36  (0.31)   9.58  (0.41) 
Treatment Week 6       
Participants Analyzed   15   20   19 
Treatment Week 6   9.57  (0.32)   9.23  (0.31)   9.54  (0.44) 
Change       
Participants Analyzed   13   17   16 
Change   0.12  (0.33)   -0.16  (0.21)   -0.03  (0.36) 

No statistical analysis provided for Laboratory Measures - Calcium



25.  Secondary:   Laboratory Measures - Sodium   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Sodium
Measure Description Sodium blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data at Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   20   20 
Laboratory Measures - Sodium 
[Units: mE/qL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   20 
Evaluation   138.53  (2.29)   139.53  (2.89)   137.30  (4.28) 
Treatment Week 6       
Participants Analyzed   15   20   19 
Treatment Week 6   138.53  (3.02)   139.15  (2.16)   137.47  (3.96) 
Change       
Participants Analyzed   13   17   16 
Change   0.15  (1.63)   -0.53  (3.22)   0.31  (2.82) 

No statistical analysis provided for Laboratory Measures - Sodium



26.  Secondary:   Laboratory Measures - Potassium   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Potassium
Measure Description Potassium blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data at Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   20   20 
Laboratory Measures - Potassium 
[Units: mE/qL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   20 
Evaluation   4.20  (0.47)   4.14  (0.31)   4.17  (0.28) 
Treatment Week 6       
Participants Analyzed   15   20   19 
Treatment Week 6   4.07  (0.32)   4.01  (0.27)   4.16  (0.39) 
Change       
Participants Analyzed   13   17   16 
Change   -0.12  (0.43)   -0.15  (0.22)   0.00  (0.31) 

No statistical analysis provided for Laboratory Measures - Potassium



27.  Secondary:   Laboratory Measures - Chloride   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Chloride
Measure Description Chloride blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   20   20 
Laboratory Measures - Chloride 
[Units: mE/qL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   20 
Evaluation   100.60  (2.95)   102.79  (3.41)   100.15  (4.21) 
Treatment Week 6       
Participants Analyzed   15   20   19 
Treatment Week 6   101.53  (3.54)   102.90  (2.63)   100.47  (3.78) 
Change       
Participants Analyzed   13   17   16 
Change   0.62  (1.89)   -0.06  (2.70)   0.56  (2.80) 

No statistical analysis provided for Laboratory Measures - Chloride



28.  Secondary:   Laboratory Measures - CO2   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - CO2
Measure Description Carbon Dioxide (CO2) blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   20   20 
Laboratory Measures - CO2 
[Units: mE/qL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   20 
Evaluation   23.47  (2.13)   22.42  (3.01)   23.40  (2.52) 
Treatment Week 6       
Participants Analyzed   15   20   18 
Treatment Week 6   23.27  (2.09)   22.50  (2.33)   22.83  (2.15) 
Change       
Participants Analyzed   13   17   15 
Change   -0.31  (2.21)   -0.06  (2.77)   -0.20  (1.52) 

No statistical analysis provided for Laboratory Measures - CO2



29.  Secondary:   Laboratory Measures - Cholesterol   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Cholesterol
Measure Description Total cholesterol blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   14   15   15 
Laboratory Measures - Cholesterol 
[Units: mg/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   11   15   15 
Evaluation   159.18  (19.18)   166.07  (35.98)   179.60  (37.43) 
Treatment Week 6       
Participants Analyzed   14   14   12 
Treatment Week 6   156.93  (22.57)   162.93  (22.57)   177.33  (36.76) 
Change       
Participants Analyzed   10   10   9 
Change   1.50  (12.61)   -2.40  (15.87)   -11.44  (31.52) 

No statistical analysis provided for Laboratory Measures - Cholesterol



30.  Secondary:   Laboratory Measures - HDL   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - HDL
Measure Description High-density lipoprotein (HDL) blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant data from Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   13   14   14 
Laboratory Measures - HDL 
[Units: mg/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   11   14   14 
Evaluation   44.09  (12.31)   45.50  (14.43)   41.14  (10.17) 
Treatment Week 6       
Participants Analyzed   13   14   12 
Treatment Week 6   44.31  (14.07)   43.64  (11.62)   41.42  (10.75) 
Change       
Participants Analyzed   10   9   9 
Change   -0.70  (6.31)   2.11  (3.69)   -1.67  (4.50) 

No statistical analysis provided for Laboratory Measures - HDL



31.  Secondary:   Laboratory Measures - LDL   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - LDL
Measure Description Low-density lipoprotein (LDL) blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   13   14   14 
Laboratory Measures - LDL 
[Units: mg/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   11   12   14 
Evaluation   90.36  (25.02)   91.25  (20.42)   105.79  (37.30) 
Treatment Week 6       
Participants Analyzed   13   14   11 
Treatment Week 6   85.92  (28.72)   92.29  (19.51)   103.73  (33.32) 
Change       
Participants Analyzed   10   8   8 
Change   -0.60  (11.58)   -1.38  (14.92)   -13.00  (26.79) 

No statistical analysis provided for Laboratory Measures - LDL



32.  Secondary:   Laboratory Measures - Triglycerides   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Triglycerides
Measure Description Triglyceride blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   14   15   15 
Laboratory Measures - Triglycerides 
[Units: mg/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   11   15   15 
Evaluation   124.55  (60.32)   155.20  (118.82)   163.47  (102.54) 
Treatment Week 6       
Participants Analyzed   14   14   12 
Treatment Week 6   124.79  (69.57)   142.29  (99.53)   162.17  (102.74) 
Change       
Participants Analyzed   10   10   9 
Change   14.00  (40.14)   -39.30  (77.44)   1.22  (49.85) 

No statistical analysis provided for Laboratory Measures - Triglycerides



33.  Secondary:   Laboratory Measures - VLDL   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - VLDL
Measure Description Very low density lipoprotein (VLDL) blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   12   13   12 
Laboratory Measures - VLDL 
[Units: mg/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   11   11   12 
Evaluation   24.73  (12.04)   22.00  (10.49)   33.17  (22.59) 
Treatment Week 6       
Participants Analyzed   12   13   11 
Treatment Week 6   26.75  (13.93)   23.62  (9.50)   28.00  (14.04) 
Change       
Participants Analyzed   10   8   7 
Change   2.80  (8.13)   -3.13  (6.31)   -0.43  (11.19) 

No statistical analysis provided for Laboratory Measures - VLDL



34.  Secondary:   Laboratory Measures - Glucose   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Glucose
Measure Description Glucose blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   18   18 
Laboratory Measures - Glucose 
[Units: mg/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   18   18 
Evaluation   108.07  (47.12)   98.61  (15.50)   103.00  (21.86) 
Treatment Week 6       
Participants Analyzed   15   16   16 
Treatment Week 6   99.67  (19.53)   102.13  (18.13)   112.31  (33.36) 
Change       
Participants Analyzed   13   13   13 
Change   -9.23  (30.91)   2.00  (20.64)   9.77  (16.51) 

No statistical analysis provided for Laboratory Measures - Glucose



35.  Secondary:   Laboratory Measures - Albumin   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Albumin
Measure Description Albumin blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   20   20 
Laboratory Measures - Albumin 
[Units: g/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   20 
Evaluation   4.39  (0.24)   4.27  (0.31)   4.35  (0.30) 
Treatment Week 6       
Participants Analyzed   15   20   19 
Treatment Week 6   4.38  (0.25)   4.23  (0.27)   4.37  (0.32) 
Change       
Participants Analyzed   13   17   16 
Change   0.04  (0.23)   -0.03  (0.35)   0.03  (0.20) 

No statistical analysis provided for Laboratory Measures - Albumin



36.  Secondary:   Laboratory Measures - Globulin   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Globulin
Measure Description Globulin blood levels by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant lab data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   14   18   19 
Laboratory Measures - Globulin 
[Units: g/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   14   18   18 
Evaluation   2.72  (0.40)   2.81  (0.42)   2.82  (0.37) 
Treatment Week 6       
Participants Analyzed   14   18   19 
Treatment Week 6   2.58  (0.54)   2.66  (0.51)   2.78  (0.38) 
Change       
Participants Analyzed   12   15   15 
Change   -0.15  (0.63)   -0.18  (0.38)   -0.09  (0.21) 

No statistical analysis provided for Laboratory Measures - Globulin



37.  Secondary:   Laboratory Measures - A/G Ratio   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - A/G Ratio
Measure Description Albumin to Globulin (A/G) ratio in the blood by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant date for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   18   19 
Laboratory Measures - A/G Ratio 
[Units: g/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   18   18 
Evaluation   1.65  (0.29)   1.58  (0.27)   1.57  (0.26) 
Treatment Week 6       
Participants Analyzed   13   17   19 
Treatment Week 6   1.71  (0.64)   1.62  (0.31)   1.60  (0.26) 
Change       
Participants Analyzed   12   14   15 
Change   0.04  (0.22)   0.05  (0.18)   0.07  (0.12) 

No statistical analysis provided for Laboratory Measures - A/G Ratio



38.  Secondary:   Laboratory Measures - Bilirubin   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Bilirubin
Measure Description Bilirubin blood level by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   20   19 
Laboratory Measures - Bilirubin 
[Units: mg/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   19 
Evaluation   0.45  (0.29)   0.35  (0.19)   0.40  (0.26) 
Treatment Week 6       
Participants Analyzed   15   20   19 
Treatment Week 6   0.49  (0.24)   0.39  (0.24)   0.38  (0.15) 
Change       
Participants Analyzed   13   17   15 
Change   0.03  (0.13)   0.05  (0.23)   0.03  (0.13) 

No statistical analysis provided for Laboratory Measures - Bilirubin



39.  Secondary:   Laboratory Measures - Protein   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - Protein
Measure Description Protein blood level by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   20   20 
Laboratory Measures - Protein 
[Units: g/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   20 
Evaluation   7.10  (0.32)   7.07  (0.41)   7.17  (0.40) 
Treatment Week 6       
Participants Analyzed   15   20   19 
Treatment Week 6   7.14  (0.42)   6.92  (0.45)   7.15  (0.42) 
Change       
Participants Analyzed   13   17   16 
Change   0.07  (0.30)   -0.13  (0.34)   -0.04  (0.37) 

No statistical analysis provided for Laboratory Measures - Protein



40.  Secondary:   Laboratory Measures - BUN   [ Time Frame: Once during evaluation and once at the end of 6 weeks of study treatment ]

Measure Type Secondary
Measure Title Laboratory Measures - BUN
Measure Description BUN blood level by treatment group and visit.
Time Frame Once during evaluation and once at the end of 6 weeks of study treatment  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Available participant data for Evaluation and Week 6.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   20   20 
Laboratory Measures - BUN 
[Units: mg/dL]
Mean (Standard Deviation)
     
Evaluation       
Participants Analyzed   15   19   20 
Evaluation   12.80  (4.92)   10.74  (3.18)   11.95  (4.10) 
Treatment Week 6       
Participants Analyzed   15   20   19 
Treatment Week 6   12.73  (4.85)   11.55  (3.41)   12.00  (4.76) 
Change       
Participants Analyzed   13   17   16 
Change   0.15  (2.82)   1.06  (3.07)   -0.06  (3.38) 

No statistical analysis provided for Laboratory Measures - BUN



41.  Secondary:   Side Effect Checklist (SEC) - Abdominal Pain   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Abdominal Pain
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Abdominal Pain" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Abdominal Pain 
[Units: Percentage of participants]
 12.5   5.0   10.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Abdominal Pain



42.  Secondary:   Side Effect Checklist (SEC) - Anorexia   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Anorexia
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Anorexia" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Anorexia 
[Units: Percentage of participants]
 18.8   10.0   15.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Anorexia



43.  Secondary:   Side Effect Checklist (SEC) - Bruising Easily   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Bruising Easily
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Bruising Easily" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Bruising Easily 
[Units: Percentage of participants]
 0.0   10.0   0.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Bruising Easily



44.  Secondary:   Side Effect Checklist (SEC) - Constipation   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Constipation
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Constipation" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Constipation 
[Units: Percentage of participants]
 0.0   0.0   0.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Constipation



45.  Secondary:   Side Effect Checklist (SEC) - Diarrhea   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Diarrhea
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Diarrhea" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Diarrhea 
[Units: Percentage of participants]
 18.8   30.0   5.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Diarrhea



46.  Secondary:   Side Effect Checklist (SEC) - Dizziness   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Dizziness
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Dizziness" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Dizziness 
[Units: Percentage of participants]
 18.8   30.0   5.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Dizziness



47.  Secondary:   Side Effect Checklist (SEC) - Dry Eye   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Dry Eye
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Dry Eye" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "dry eye" data.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   18   17 
Side Effect Checklist (SEC) - Dry Eye 
[Units: Percentage of participants]
 6.7   0.0   5.9 

No statistical analysis provided for Side Effect Checklist (SEC) - Dry Eye



48.  Secondary:   Side Effect Checklist (SEC) - Dry Mouth   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Dry Mouth
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Dry Mouth" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Dry Mouth 
[Units: Percentage of participants]
 18.8   5.0   10.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Dry Mouth



49.  Secondary:   Side Effect Checklist (SEC) - Enuresis   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Enuresis
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Enuresis" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Enuresis 
[Units: Percentage of participants]
 25.0   5.0   0.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Enuresis



50.  Secondary:   Side Effect Checklist (SEC) - Excessive Tearing of the Eye   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Excessive Tearing of the Eye
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Excessive Tearing of the Eye" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "excessive tearing of the eye" data.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   18   17 
Side Effect Checklist (SEC) - Excessive Tearing of the Eye 
[Units: Percentage of participants]
 6.7   5.6   5.9 

No statistical analysis provided for Side Effect Checklist (SEC) - Excessive Tearing of the Eye



51.  Secondary:   Side Effect Checklist (SEC) - Fever   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Fever
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Fever" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Fever 
[Units: Percentage of participants]
 0.0   5.0   0.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Fever



52.  Secondary:   Side Effect Checklist (SEC) - Headache   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Headache
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Headache" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Headache 
[Units: Percentage of participants]
 12.5   25.0   15.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Headache



53.  Secondary:   Side Effect Checklist (SEC) - Hyperhydrosis   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Hyperhydrosis
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Hyperhydrosis" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "Hyperhydrosis" data.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   15   18   17 
Side Effect Checklist (SEC) - Hyperhydrosis 
[Units: Percentage of participants]
 0.0   0.0   0.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Hyperhydrosis



54.  Secondary:   Side Effect Checklist (SEC) - Hypersalivation   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Hypersalivation
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Hypersalivation" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Hypersalivation 
[Units: Percentage of participants]
 18.8   15.0   25.0 

No statistical analysis provided for Side Effect Checklist (SEC) - Hypersalivation



55.  Secondary:   Side Effect Checklist (SEC) - Insomnia   [ Time Frame: Weekly for 6 weeks ]

Measure Type Secondary
Measure Title Side Effect Checklist (SEC) - Insomnia
Measure Description Percentage of participants with new onset or worsening compared to baseline of "Insomnia" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety data for 56 participants exposed to study treatment.

Reporting Groups
  Description
1: Oxytocin Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
2: Galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
3: Placebo Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin

Measured Values
   1: Oxytocin   2: Galantamine   3: Placebo 
Participants Analyzed   16   20   20 
Side Effect Checklist (SEC) - Insomnia 
[Units: Percentage of participants]
 18.8