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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
Enrollment 86

Recruitment Details  
Pre-assignment Details

Consented/Screened for Study-- N=86

Withdrew prior to randomization (N=28)

  • 2 withdrew consent
  • 26 did not meet inclusion criteria

Randomized-- N=58

Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine Subjects randomized to galantamine will receive galantamine and placebo-oxytocin Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Period Title: Overall Study
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Withdrawn Prior to Study Drug Exposure 1 0 1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
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo Total
Hide Arm/Group Description Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks 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. Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day. Total of all reporting groups
Overall Number of Baseline Participants 16 20 20 56
Hide Baseline Analysis Population Description
Number of participants randomized N=58 Withdrawn prior to exposure to study drug (N=2) Oxytocin N=1 withdrawn due to abnormal EKG Placebo N=1 Participant withdrew consent Exposed to study drug N=56
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 20 participants 20 participants 56 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 20 participants 20 participants 56 participants
47.4  (11.2) 45.8  (12.4) 42.2  (11.7) 44.9  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 20 participants 20 participants 56 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 20 participants 20 participants 56 participants
16 20 20 56
1.Primary Outcome
Title Scale for the Assessment of Negative Symptoms (SANS) Total Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 Number Analyzed 15 participants 19 participants 19 participants
33.23  (6.91) 36.63  (10.09) 36.63  (10.61)
Treatment Week 2 Number Analyzed 15 participants 19 participants 19 participants
30.07  (6.93) 35.22  (10.97) 35.05  (10.52)
Treatment Week 4 Number Analyzed 15 participants 18 participants 18 participants
31.27  (7.53) 34.06  (10.26) 34.22  (9.61)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
31.40  (6.85) 33.22  (10.64) 33.47  (8.47)
Change from Week 0 at Week 2 Number Analyzed 15 participants 19 participants 19 participants
-3.17  (4.20) -1.41  (3.32) -1.58  (4.84)
Change from Week 0 at Week 4 Number Analyzed 15 participants 18 participants 18 participants
-1.97  (4.48) -1.69  (3.46) -1.47  (5.64)
Change from Week 0 at Week 6 Number Analyzed 15 participants 18 participants 17 participants
-1.83  (3.74) -2.53  (4.34) -1.00  (4.41)
2.Primary Outcome
Title Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 14 15 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 Number Analyzed 14 participants 15 participants 16 participants
0.23  (0.92) -0.22  (0.47) 0.21  (0.83)
Treatment Week 6 Number Analyzed 14 participants 15 participants 15 participants
0.33  (1) -0.05  (0.68) 0.18  (0.69)
Change Number Analyzed 14 participants 15 participants 15 participants
0.1  (0.37) 0.17  (0.44) 0.03  (0.41)
3.Secondary Outcome
Title Scale for the Assessment of Negative Symptoms (SANS) - Avolition
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 Number Analyzed 15 participants 19 participants 19 participants
2.94  (0.90) 2.91  (0.88) 2.44  (0.97)
Treatment Week 2 Number Analyzed 15 participants 19 participants 19 participants
2.78  (0.77) 2.73  (0.74) 2.43  (0.93)
Treatment Week 4 Number Analyzed 15 participants 18 participants 18 participants
2.85  (1.04) 2.74  (.084) 2.44  (0.94)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
2.88  (0.89) 2.74  (0.90) 2.41  (0.87)
Change from Week 0 at Week 2 Number Analyzed 15 participants 19 participants 19 participants
-0.15  (0.32) -0.18  (0.43) -0.01  (0.57)
Change from Week 0 at Week 4 Number Analyzed 15 participants 18 participants 18 participants
-0.09  (0.31) -0.16  (0.50) 0.04  (0.43)
Change from Week 0 at Week 6 Number Analyzed 15 participants 18 participants 17 participants
-0.05  (0.48) -0.16  (0.69) 0.05  (0.46)
4.Secondary Outcome
Title Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 Number Analyzed 15 participants 19 participants 19 participants
2.42  (0.59) 2.60  (0.80) 2.66  (0.69)
Treatment Week 2 Number Analyzed 15 participants 19 participants 19 participants
2.42  (0.64) 2.59  (0.86) 2.58  (0.66)
Treatment Week 4 Number Analyzed 15 participants 18 participants 18 participants
2.27  (0.78) 2.46  (0.99) 2.60  (0.64)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
2.33  (0.49) 2.43  (0.98) 2.66  (0.60)
Change from Week 0 at Week 2 Number Analyzed 15 participants 19 participants 19 participants
0.00  (0.37) -0.01  (0.40) -0.08  (0.51)
Change from Week 0 at Week 4 Number Analyzed 15 participants 18 participants 18 participants
-0.15  (0.68) -0.11  (.013) 0.01  (0.50)
Change from Week 0 at Week 6 Number Analyzed 15 participants 18 participants 17 participants
-0.09  (0.38) -0.14  (0.38) 0.12  (0.47)
5.Secondary Outcome
Title Scale for the Assessment of Negative Symptoms (SANS) - Alogia
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 Number Analyzed 15 participants 19 participants 19 participants
0.60  (0.61) 0.95  (0.65) 0.99  (0.69)
Treatment Week 2 Number Analyzed 15 participants 19 participants 19 participants
0.44  (0.67) 0.89  (0.59) 0.89  (0.80)
Treatment Week 4 Number Analyzed 15 participants 18 participants 18 participants
0.56  (0.70) 0.85  (0.50) 0.80  (0.61)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
0.56  (0.69) 0.78  (0.44) 0.69  (0.57)
Change from Week 0 at Week 2 Number Analyzed 15 participants 19 participants 19 participants
-0.16  (0.42) -0.05  (0.36) -0.10  (0.35)
Change from Week 0 at Week 4 Number Analyzed 15 participants 18 participants 18 participants
-0.04  (0.41) -0.03  (0.37) -0.17  (0.31)
Change from Week 0 at Week 6 Number Analyzed 15 participants 18 participants 17 participants
-0.04  (0.46) -0.10  (0.31) -0.19  (0.31)
6.Secondary Outcome
Title Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 Number Analyzed 15 participants 19 participants 19 participants
1.67  (0.86) 1.96  (1.06) 2.21  (0.97)
Treatment Week 2 Number Analyzed 15 participants 19 participants 19 participants
1.32  (0.90) 1.89  (1.10) 2.05  (1.12)
Treatment Week 4 Number Analyzed 15 participants 18 participants 18 participants
1.52  (0.91) 1.79  (0.99) 1.94  (0.98)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
1.48  (0.96) 1.70  (1.05) 1.85  (0.94)
Change from Week 0 at Week 2 Number Analyzed 15 participants 19 participants 19 participants
-0.35  (0.36) -0.07  (0.36) -0.16  (0.47)
Change from Week 0 at Week 4 Number Analyzed 15 participants 18 participants 18 participants
-0.15  (0.44) -0.09  (0.33) -0.19  (0.60)
Change from Week 0 at Week 6 Number Analyzed 15 participants 18 participants 17 participants
-0.19  (0.36) -0.17  (0.40) -0.19  (0.38)
7.Secondary Outcome
Title Brief Psychiatric Rating Scale (BPRS) - Total Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data available for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 Number Analyzed 16 participants 20 participants 20 participants
34.16  (5.66) 30.35  (6.66) 32.65  (7.09)
Treatment Week 2 Number Analyzed 15 participants 19 participants 20 participants
34.00  (7.46) 28.95  (7.83) 31.75  (7.26)
Treatment Week 4 Number Analyzed 15 participants 18 participants 18 participants
34.07  (6.15) 27.83  (6.88) 31.72  (7.25)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
34.33  (5.09) 27.67  (6.42) 32.18  (6.21)
8.Secondary Outcome
Title Brief Psychiatric Rating Scale (BPRS) - Psychosis Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data available for the 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
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.
Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
Overall Number of Participants Analyzed 16 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 Number Analyzed 16 participants 20 participants 20 participants
9.34  (3.20) 7.30  (3.01) 8.18  (3.80)
Treatment Week 2 Number Analyzed 15 participants 19 participants 20 participants
9.40  (3.79) 7.21  (3.61) 7.90  (3.86)
Treatment Week 4 Number Analyzed 15 participants 18 participants 18 participants
9.87  (3.60) 7.00  (3.48) 8.06  (4.09)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
9.67  (2.87) 6.78  (3.21) 7.59  (4.35)
9.Secondary Outcome
Title Calgary Depression Scale (CDS) - Total Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 19 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 Number Analyzed 15 participants 19 participants 19 participants
2.37  (2.70) 0.84  (1.07) 1.59  (1.54)
Treatment Week 2 Number Analyzed 15 participants 19 participants 19 participants
2.20  (2.54) 1.05  (1.65) 1.00  (1.29)
Treatment Week 4 Number Analyzed 15 participants 18 participants 18 participants
2.13  (2.13) 0.67  (1.28) 0.94  (1.97)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
1.67  (2.47) 0.50  (0.71) 1.29  (1.45)
10.Secondary Outcome
Title Arizona Sexual Experience Questionnaire (ASEX) Female
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Female participants who completed at least two weeks follow-up.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 2 6 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 Number Analyzed 2 participants 6 participants 3 participants
10.5  (0.7) 21.2  (7.6) 29.0  (1.7)
Treatment Week 6 Number Analyzed 2 participants 6 participants 2 participants
13.5  (0.7) 19.2  (9.3) 30.0  (0)
Change Number Analyzed 2 participants 6 participants 2 participants
3.0  (0.0) -2.0  (3.5) 0.0  (0.0)
11.Secondary Outcome
Title Arizona Sexual Experience Questionnaire (ASEX) Male
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Male participants who completed at least two weeks follow-up.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 14 14 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 Number Analyzed 13 participants 14 participants 16 participants
16.5  (9.2) 18.1  (6.7) 20.8  (6.3)
Treatment Week 6 Number Analyzed 14 participants 12 participants 13 participants
17.1  (8.5) 20.2  (7.5) 21.7  (7.7)
Change Number Analyzed 14 participants 12 participants 12 participants
1.5  (7.8) 1.6  (5.0) 0.8  (6.2)
12.Secondary Outcome
Title Vital Signs - Diastolic Blood Pressure
Hide Description Mean diastolic blood pressure by treatment and follow-up week
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Mean (Standard Deviation)
Unit of Measure: mm-Hg
Treatment Week 0 Number Analyzed 16 participants 20 participants 20 participants
78.8  (8.3) 76.6  (10.7) 78.3  (10.1)
Treatment Week 1 Number Analyzed 15 participants 19 participants 19 participants
78.4  (9.0) 76.2  (8.9) 75.5  (10.8)
Treatment Week 2 Number Analyzed 15 participants 19 participants 19 participants
76.7  (9.1) 77.5  (8.4) 79.7  (10.6)
Treatment Week 3 Number Analyzed 15 participants 16 participants 19 participants
75.0  (10.6) 79.1  (6.9) 78.9  (8.1)
Treatment Week 4 Number Analyzed 15 participants 18 participants 18 participants
73.9  (8.2) 75.1  (7.3) 73.7  (9.7)
Treatment Week 5 Number Analyzed 15 participants 16 participants 17 participants
76.2  (8.8) 79.2  (8.4) 77.2  (10.9)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
74.4  (8.3) 80.7  (6.9) 76.0  (9.9)
13.Secondary Outcome
Title Vital Signs - Systolic Blood Pressure
Hide Description Mean systolic blood pressure by treatment and follow-up week
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Mean (Standard Deviation)
Unit of Measure: mm-Hg
Treatment Week 0 Number Analyzed 16 participants 20 participants 20 participants
128.4  (16.7) 123.4  (17.3) 132.3  (19.6)
Treatment Week 1 Number Analyzed 15 participants 19 participants 19 participants
126.1  (16.9) 123.9  (15.0) 127.4  (22.1)
Treatment Week 2 Number Analyzed 15 participants 19 participants 19 participants
121.9  (20.5) 123.7  (13.8) 136.2  (25.1)
Treatment Week 3 Number Analyzed 15 participants 16 participants 19 participants
129.5  (21.1) 127.3  (19.0) 137.7  (17.0)
Treatment Week 4 Number Analyzed 15 participants 18 participants 18 participants
124.8  (17.3) 123.8  (19.0) 129.9  (16.5)
Treatment Week 5 Number Analyzed 15 participants 16 participants 17 participants
128.4  (20.5) 126.9  (20.1) 132.8  (19.5)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
124.0  (17.5) 129.6  (16.1) 134.5  (19.4)
14.Secondary Outcome
Title Vital Signs - Weight
Hide Description Mean weight (kg) by treatment and follow-up week
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Mean (Standard Deviation)
Unit of Measure: kg
Treatment Week 0 Number Analyzed 16 participants 20 participants 20 participants
96.5  (18.4) 96.2  (16.2) 96.4  (20.0)
Treatment Week 1 Number Analyzed 15 participants 19 participants 18 participants
97.8  (19.1) 97.5  (16.0) 97.9  (18.9)
Treatment Week 2 Number Analyzed 15 participants 19 participants 19 participants
98.0  (18.9) 97.5  (16.1) 98.3  (18.8)
Treatment Week 3 Number Analyzed 15 participants 16 participants 19 participants
98.0  (18.9) 94.5  (13.8) 98.4  (19.5)
Treatment Week 4 Number Analyzed 14 participants 18 participants 18 participants
100.0  (17.9) 95.5  (14.4) 100.3  (17.7)
Treatment Week 5 Number Analyzed 15 participants 16 participants 17 participants
98.1  (18.6) 94.0  (14.6) 100.8  (17.7)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
97.6  (18.0) 95.1  (14.7) 97.9  (16.3)
15.Secondary Outcome
Title Vital Signs - Pulse
Hide Description Mean sitting pulse (bpm) by treatment and follow-up week
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Mean (Standard Deviation)
Unit of Measure: bpm
Treatment Week 0 Number Analyzed 16 participants 20 participants 20 participants
81.2  (10.4) 86.0  (14.1) 85.2  (13.4)
Treatment Week 1 Number Analyzed 15 participants 19 participants 19 participants
86.2  (18.8) 91.6  (14.9) 89.3  (16.7)
Treatment Week 2 Number Analyzed 15 participants 19 participants 19 participants
82.7  (17.3) 91.3  (14.2) 87.3  (15.3)
Treatment Week 3 Number Analyzed 15 participants 16 participants 19 participants
76.5  (11.5) 89.2  (15.6) 89.2  (13.8)
Treatment Week 4 Number Analyzed 15 participants 18 participants 18 participants
79.6  (13.2) 88.6  (12.9) 83.7  (14.2)
Treatment Week 5 Number Analyzed 15 participants 16 participants 17 participants
78.4  (13.2) 98.6  (28.1) 90.5  (16.0)
Treatment Week 6 Number Analyzed 15 participants 18 participants 17 participants
76.1  (15.0) 85.2  (16.6) 84.7  (12.2)
16.Secondary Outcome
Title Simpson-Angus Scale (SAS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 19 19
Measure Type: Number
Unit of Measure: 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
17.Secondary Outcome
Title Abnormal Involuntary Movement Scale (AIMS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
50 participants who completed the trial.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 17
Measure Type: Number
Unit of Measure: 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
18.Secondary Outcome
Title Electrocardiogram (EKG)
Hide Description Mean corrected QT interval (QTc) by study week and treatment.
Time Frame Once during Evaluation and once at Treatment Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
50 participants who completed the trial.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 17
Mean (Standard Deviation)
Unit of Measure: QTc
Evaluation Week 0 Number Analyzed 14 participants 17 participants 17 participants
416.5  (23.1) 419.0  (26.6) 422.6  (25.5)
Treatment Week 6 Number Analyzed 15 participants 18 participants 16 participants
415.7  (28.3) 408.1  (27.2) 423.8  (26.7)
Change Number Analyzed 14 participants 17 participants 16 participants
-2.9  (20.7) -10.2  (18.3) 0.9  (20.3)
19.Secondary Outcome
Title Barnes Akathisia Scale (BAS) - Global Score
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
50 participants who completed the trial.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 17
Measure Type: Number
Unit of Measure: percentage of participants
No worsening (0) 93.33 100 94.12
Worsening of 1 6.67 0 5.88
20.Secondary Outcome
Title Blood Oxytocin Levels
Hide Description Blood Oxytocin Levels by Treatment and Visit
Time Frame Treatment Week 0 and Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin.
Overall Number of Participants Analyzed 16 20 17
Mean (Standard Deviation)
Unit of Measure: pg/mL
Treatment Week 0 Number Analyzed 16 participants 20 participants 17 participants
18.22  (15.52) 13.76  (6.96) 14.69  (7.99)
Treatment Week 6 Number Analyzed 14 participants 15 participants 13 participants
17.22  (17.02) 10.11  (3.42) 13.21  (9.32)
Change Number Analyzed 14 participants 15 participants 11 participants
-1.88  (14.09) -2.99  (5.2) -1.73  (3.95)
21.Secondary Outcome
Title Laboratory Measures - ALT/SGPT
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data at Evaluation and Week 6.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 20
Mean (Standard Deviation)
Unit of Measure: U/L
Evaluation Number Analyzed 15 participants 19 participants 20 participants
22.87  (8.68) 31.26  (22.93) 27.40  (19.78)
Treatment Week 6 Number Analyzed 15 participants 20 participants 19 participants
20.67  (13.03) 28.90  (22.81) 27.74  (16.62)
Change Number Analyzed 13 participants 17 participants 16 participants
-2.15  (10.20) -2.65  (6.14) 0.31  (8.10)
22.Secondary Outcome
Title Laboratory Measures - AST/SGOT
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data at Evaluation and Week 6.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 20
Mean (Standard Deviation)
Unit of Measure: U/L
Evaluation Number Analyzed 15 participants 19 participants 20 participants
19.87  (5.46) 22.68  (9.68) 22.50  (9.29)
Treatment Week 6 Number Analyzed 15 participants 20 participants 19 participants
20.27  (8.94) 21.45  (10.16) 23.58  (9.26)
Change Number Analyzed 13 participants 17 participants 16 participants
-1.46  (4.20) -1.53  (8.13) 1.00  (5.43)
23.Secondary Outcome
Title Laboratory Measures - Alkaline Phosphatase
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data at Evaluation at Week 6.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 20
Mean (Standard Deviation)
Unit of Measure: U/L
Evaluation Number Analyzed 15 participants 19 participants 20 participants
83.47  (21.56) 83.42  (16.29) 86.40  (23.37)
Treatment Week 6 Number Analyzed 15 participants 20 participants 19 participants
78.73  (31.09) 82.50  (20.50) 88.95  (29.67)
Change Number Analyzed 13 participants 17 participants 16 participants
-4.77  (15.81) 0.88  (10.29) 1.19  (10.97)
24.Secondary Outcome
Title Laboratory Measures - Calcium
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data at Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 20
Mean (Standard Deviation)
Unit of Measure: mg/dL
Evaluation Number Analyzed 15 participants 19 participants 20 participants
9.53  (0.33) 9.36  (0.31) 9.58  (0.41)
Treatment Week 6 Number Analyzed 15 participants 20 participants 19 participants
9.57  (0.32) 9.23  (0.31) 9.54  (0.44)
Change Number Analyzed 13 participants 17 participants 16 participants
0.12  (0.33) -0.16  (0.21) -0.03  (0.36)
25.Secondary Outcome
Title Laboratory Measures - Sodium
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data at Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 20
Mean (Standard Deviation)
Unit of Measure: mE/qL
Evaluation Number Analyzed 15 participants 19 participants 20 participants
138.53  (2.29) 139.53  (2.89) 137.30  (4.28)
Treatment Week 6 Number Analyzed 15 participants 20 participants 19 participants
138.53  (3.02) 139.15  (2.16) 137.47  (3.96)
Change Number Analyzed 13 participants 17 participants 16 participants
0.15  (1.63) -0.53  (3.22) 0.31  (2.82)
26.Secondary Outcome
Title Laboratory Measures - Potassium
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data at Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 20
Mean (Standard Deviation)
Unit of Measure: mE/qL
Evaluation Number Analyzed 15 participants 19 participants 20 participants
4.20  (0.47) 4.14  (0.31) 4.17  (0.28)
Treatment Week 6 Number Analyzed 15 participants 20 participants 19 participants
4.07  (0.32) 4.01  (0.27) 4.16  (0.39)
Change Number Analyzed 13 participants 17 participants 16 participants
-0.12  (0.43) -0.15  (0.22) 0.00  (0.31)
27.Secondary Outcome
Title Laboratory Measures - Chloride
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 20
Mean (Standard Deviation)
Unit of Measure: mE/qL
Evaluation Number Analyzed 15 participants 19 participants 20 participants
100.60  (2.95) 102.79  (3.41) 100.15  (4.21)
Treatment Week 6 Number Analyzed 15 participants 20 participants 19 participants
101.53  (3.54) 102.90  (2.63) 100.47  (3.78)
Change Number Analyzed 13 participants 17 participants 16 participants
0.62  (1.89) -0.06  (2.70) 0.56  (2.80)
28.Secondary Outcome
Title Laboratory Measures - CO2
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 20
Mean (Standard Deviation)
Unit of Measure: mE/qL
Evaluation Number Analyzed 15 participants 19 participants 20 participants
23.47  (2.13) 22.42  (3.01) 23.40  (2.52)
Treatment Week 6 Number Analyzed 15 participants 20 participants 18 participants
23.27  (2.09) 22.50  (2.33) 22.83  (2.15)
Change Number Analyzed 13 participants 17 participants 15 participants
-0.31  (2.21) -0.06  (2.77) -0.20  (1.52)
29.Secondary Outcome
Title Laboratory Measures - Cholesterol
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 14 15 15
Mean (Standard Deviation)
Unit of Measure: mg/dL
Evaluation Number Analyzed 11 participants 15 participants 15 participants
159.18  (19.18) 166.07  (35.98) 179.60  (37.43)
Treatment Week 6 Number Analyzed 14 participants 14 participants 12 participants
156.93  (22.57) 162.93  (22.57) 177.33  (36.76)
Change Number Analyzed 10 participants 10 participants 9 participants
1.50  (12.61) -2.40  (15.87) -11.44  (31.52)
30.Secondary Outcome
Title Laboratory Measures - HDL
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant data from Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 13 14 14
Mean (Standard Deviation)
Unit of Measure: mg/dL
Evaluation Number Analyzed 11 participants 14 participants 14 participants
44.09  (12.31) 45.50  (14.43) 41.14  (10.17)
Treatment Week 6 Number Analyzed 13 participants 14 participants 12 participants
44.31  (14.07) 43.64  (11.62) 41.42  (10.75)
Change Number Analyzed 10 participants 9 participants 9 participants
-0.70  (6.31) 2.11  (3.69) -1.67  (4.50)
31.Secondary Outcome
Title Laboratory Measures - LDL
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 13 14 14
Mean (Standard Deviation)
Unit of Measure: mg/dL
Evaluation Number Analyzed 11 participants 12 participants 14 participants
90.36  (25.02) 91.25  (20.42) 105.79  (37.30)
Treatment Week 6 Number Analyzed 13 participants 14 participants 11 participants
85.92  (28.72) 92.29  (19.51) 103.73  (33.32)
Change Number Analyzed 10 participants 8 participants 8 participants
-0.60  (11.58) -1.38  (14.92) -13.00  (26.79)
32.Secondary Outcome
Title Laboratory Measures - Triglycerides
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 14 15 15
Mean (Standard Deviation)
Unit of Measure: mg/dL
Evaluation Number Analyzed 11 participants 15 participants 15 participants
124.55  (60.32) 155.20  (118.82) 163.47  (102.54)
Treatment Week 6 Number Analyzed 14 participants 14 participants 12 participants
124.79  (69.57) 142.29  (99.53) 162.17  (102.74)
Change Number Analyzed 10 participants 10 participants 9 participants
14.00  (40.14) -39.30  (77.44) 1.22  (49.85)
33.Secondary Outcome
Title Laboratory Measures - VLDL
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 12 13 12
Mean (Standard Deviation)
Unit of Measure: mg/dL
Evaluation Number Analyzed 11 participants 11 participants 12 participants
24.73  (12.04) 22.00  (10.49) 33.17  (22.59)
Treatment Week 6 Number Analyzed 12 participants 13 participants 11 participants
26.75  (13.93) 23.62  (9.50) 28.00  (14.04)
Change Number Analyzed 10 participants 8 participants 7 participants
2.80  (8.13) -3.13  (6.31) -0.43  (11.19)
34.Secondary Outcome
Title Laboratory Measures - Glucose
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 18
Mean (Standard Deviation)
Unit of Measure: mg/dL
Evaluation Number Analyzed 15 participants 18 participants 18 participants
108.07  (47.12) 98.61  (15.50) 103.00  (21.86)
Treatment Week 6 Number Analyzed 15 participants 16 participants 16 participants
99.67  (19.53) 102.13  (18.13) 112.31  (33.36)
Change Number Analyzed 13 participants 13 participants 13 participants
-9.23  (30.91) 2.00  (20.64) 9.77  (16.51)
35.Secondary Outcome
Title Laboratory Measures - Albumin
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 20
Mean (Standard Deviation)
Unit of Measure: g/dL
Evaluation Number Analyzed 15 participants 19 participants 20 participants
4.39  (0.24) 4.27  (0.31) 4.35  (0.30)
Treatment Week 6 Number Analyzed 15 participants 20 participants 19 participants
4.38  (0.25) 4.23  (0.27) 4.37  (0.32)
Change Number Analyzed 13 participants 17 participants 16 participants
0.04  (0.23) -0.03  (0.35) 0.03  (0.20)
36.Secondary Outcome
Title Laboratory Measures - Globulin
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant lab data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 14 18 19
Mean (Standard Deviation)
Unit of Measure: g/dL
Evaluation Number Analyzed 14 participants 18 participants 18 participants
2.72  (0.40) 2.81  (0.42) 2.82  (0.37)
Treatment Week 6 Number Analyzed 14 participants 18 participants 19 participants
2.58  (0.54) 2.66  (0.51) 2.78  (0.38)
Change Number Analyzed 12 participants 15 participants 15 participants
-0.15  (0.63) -0.18  (0.38) -0.09  (0.21)
37.Secondary Outcome
Title Laboratory Measures - A/G Ratio
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant date for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 19
Mean (Standard Deviation)
Unit of Measure: g/dL
Evaluation Number Analyzed 15 participants 18 participants 18 participants
1.65  (0.29) 1.58  (0.27) 1.57  (0.26)
Treatment Week 6 Number Analyzed 13 participants 17 participants 19 participants
1.71  (0.64) 1.62  (0.31) 1.60  (0.26)
Change Number Analyzed 12 participants 14 participants 15 participants
0.04  (0.22) 0.05  (0.18) 0.07  (0.12)
38.Secondary Outcome
Title Laboratory Measures - Bilirubin
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 19
Mean (Standard Deviation)
Unit of Measure: mg/dL
Evaluation Number Analyzed 15 participants 19 participants 19 participants
0.45  (0.29) 0.35  (0.19) 0.40  (0.26)
Treatment Week 6 Number Analyzed 15 participants 20 participants 19 participants
0.49  (0.24) 0.39  (0.24) 0.38  (0.15)
Change Number Analyzed 13 participants 17 participants 15 participants
0.03  (0.13) 0.05  (0.23) 0.03  (0.13)
39.Secondary Outcome
Title Laboratory Measures - Protein
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 20
Mean (Standard Deviation)
Unit of Measure: g/dL
Evaluation Number Analyzed 15 participants 19 participants 20 participants
7.10  (0.32) 7.07  (0.41) 7.17  (0.40)
Treatment Week 6 Number Analyzed 15 participants 20 participants 19 participants
7.14  (0.42) 6.92  (0.45) 7.15  (0.42)
Change Number Analyzed 13 participants 17 participants 16 participants
0.07  (0.30) -0.13  (0.34) -0.04  (0.37)
40.Secondary Outcome
Title Laboratory Measures - BUN
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Available participant data for Evaluation and Week 6.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 20 20
Mean (Standard Deviation)
Unit of Measure: mg/dL
Evaluation Number Analyzed 15 participants 19 participants 20 participants
12.80  (4.92) 10.74  (3.18) 11.95  (4.10)
Treatment Week 6 Number Analyzed 15 participants 20 participants 19 participants
12.73  (4.85) 11.55  (3.41) 12.00  (4.76)
Change Number Analyzed 13 participants 17 participants 16 participants
0.15  (2.82) 1.06  (3.07) -0.06  (3.38)
41.Secondary Outcome
Title Side Effect Checklist (SEC) - Abdominal Pain
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
12.5 5.0 10.0
42.Secondary Outcome
Title Side Effect Checklist (SEC) - Anorexia
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
18.8 10.0 15.0
43.Secondary Outcome
Title Side Effect Checklist (SEC) - Bruising Easily
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
0.0 10.0 0.0
44.Secondary Outcome
Title Side Effect Checklist (SEC) - Constipation
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0
45.Secondary Outcome
Title Side Effect Checklist (SEC) - Diarrhea
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
18.8 30.0 5.0
46.Secondary Outcome
Title Side Effect Checklist (SEC) - Dizziness
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
18.8 30.0 5.0
47.Secondary Outcome
Title Side Effect Checklist (SEC) - Dry Eye
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "dry eye" data.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 17
Measure Type: Number
Unit of Measure: percentage of participants
6.7 0.0 5.9
48.Secondary Outcome
Title Side Effect Checklist (SEC) - Dry Mouth
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
18.8 5.0 10.0
49.Secondary Outcome
Title Side Effect Checklist (SEC) - Enuresis
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
25.0 5.0 0.0
50.Secondary Outcome
Title Side Effect Checklist (SEC) - Excessive Tearing of the Eye
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "excessive tearing of the eye" data.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 17
Measure Type: Number
Unit of Measure: percentage of participants
6.7 5.6 5.9
51.Secondary Outcome
Title Side Effect Checklist (SEC) - Fever
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
0.0 5.0 0.0
52.Secondary Outcome
Title Side Effect Checklist (SEC) - Headache
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
12.5 25.0 15.0
53.Secondary Outcome
Title Side Effect Checklist (SEC) - Hyperhydrosis
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "Hyperhydrosis" data.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 17
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0
54.Secondary Outcome
Title Side Effect Checklist (SEC) - Hypersalivation
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
18.8 15.0 25.0
55.Secondary Outcome
Title Side Effect Checklist (SEC) - Insomnia
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
18.8 10.0 5.0
56.Secondary Outcome
Title Side Effect Checklist (SEC) - Malaise
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Malaise" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
18.8 0.0 10.0
57.Secondary Outcome
Title Side Effect Checklist (SEC) - Mucosal Ulceration
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Mucosal Ulceration" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
6.3 5.0 0.0
58.Secondary Outcome
Title Side Effect Checklist (SEC) - Nasal Irritation
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Nasal Irritation" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "nasal irritation" data.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 17
Measure Type: Number
Unit of Measure: percentage of participants
33.3 16.7 23.5
59.Secondary Outcome
Title Side Effect Checklist (SEC) - Nausea
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Nausea" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
18.8 15.0 5.0
60.Secondary Outcome
Title Side Effect Checklist (SEC) - Rash
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Rash" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
12.5 10.0 10.0
61.Secondary Outcome
Title Side Effect Checklist (SEC) - Restlessness
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Restlessness" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
18.8 10.0 15.0
62.Secondary Outcome
Title Side Effect Checklist (SEC) - Sedation
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Sedation" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
12.5 15.0 10.0
63.Secondary Outcome
Title Side Effect Checklist (SEC) - Sore Throat
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Sore Throat" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
6.3 10.0 5.0
64.Secondary Outcome
Title Side Effect Checklist (SEC) - Stiffness
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Stiffness" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
6.3 10.0 10.0
65.Secondary Outcome
Title Side Effect Checklist (SEC) - Tinnitus
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Tinnitus" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 19
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 10.5
66.Secondary Outcome
Title Side Effect Checklist (SEC) - Tremor
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Tremor" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
6.3 15.0 10.0
67.Secondary Outcome
Title Side Effect Checklist (SEC) - Urticaria
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Urticaria" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
18.8 15.0 15.0
68.Secondary Outcome
Title Side Effect Checklist (SEC) - Uterine Contractions
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Uterine Contractions" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Female participants
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 2 6 3
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0
69.Secondary Outcome
Title Side Effect Checklist (SEC) - Vomiting
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Vomiting" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
12.5 5.0 10.0
70.Secondary Outcome
Title Side Effect Checklist (SEC) - Weight Loss
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Weight Loss" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 16 20 20
Measure Type: Number
Unit of Measure: percentage of participants
18.8 5.0 25.0
71.Secondary Outcome
Title Side Effect Checklist (SEC) - Wheezing
Hide Description Percentage of participants with new onset or worsening compared to baseline of "Wheezing" rating on the SEC, by Treatment Group.
Time Frame Weekly for 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety data for 56 participants exposed to study treatment minus 6 participants with missing "wheezing" data.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 17
Measure Type: Number
Unit of Measure: percentage of participants
13.3 5.6 11.8
72.Secondary Outcome
Title Neurocognitive Assessment Battery (MCCB) - Composite Score
Hide Description MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome.
Time Frame Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
Arm/Group Title 1: Oxytocin/Placebo-galantamine 2: Galantamine/Placebo-oxytocin 3: Placebo-galantamine /Placebo-oxytocin
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 16 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 25.9  (13.0) 24.5  (9.7) 28.2  (9.6)
Treatment Week 6 28.2  (14.1) 26.2  (11.1) 28.9  (11.8)
Change 2.3  (3.9) 1.7  (4.0) 0.7  (8.0)
73.Secondary Outcome
Title Neurocognitive Assessment Battery (MCCB) - Attention Vigilance
Hide Description

MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome.

Time Frame Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 17 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 36.9  (8.8) 33.5  (14.5) 37.2  (10.9)
Treatment Week 6 39.5  (11.3) 34.5  (13.6) 35.1  (12.7)
Change 2.6  (5.8) 1.1  (6.9) -2.1  (6.9)
74.Secondary Outcome
Title Neurocognitive Assessment Battery (MCCB) - Processing Speed
Hide Description MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome.
Time Frame Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 33.5  (13.1) 31.9  (11.7) 34.0  (10.9)
Treatment Week 6 34.2  (11.6) 35.4  (8.6) 35.6  (12.7)
Change 0.7  (4.3) 3.5  (5.6) 1.6  (7.3)
75.Secondary Outcome
Title Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving
Hide Description MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.
Time Frame Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
Overall Number of Participants Analyzed 15 18 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Treatment Week 0 39.7  (10.8) 39.3  (6.8) 41.4  (8.4)
Treatment Week 6 40.7  (9.4) 42.9  (8.3) 41.7  (9.7)
Change 1.0  (8.1) 3.7  (5.1) 0.3  (10.1)
76.Secondary Outcome
Title Neurocognitive Assessment Battery (MCCB) - Social Cognition
Hide Description MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome.
Time Frame Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.
Arm/Group Title 1: Oxytocin 2: Galantamine 3: Placebo
Hide Arm/Group Description:
Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
Subjects randomized to galantamine will receive galantamine and placebo-oxytocin