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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Withdrawn Prior to Study Drug Exposure   1   0   1 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Withdrawn prior to exposure to study drug (N=2) Oxytocin N=1 withdrawn due to abnormal EKG Placebo N=1 Participant withdrew consent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 ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

57.  Secondary:   Side Effect Checklist (SEC) - Mucosal Ulceration   [ Time Frame: Weekly for 6 weeks ]

58.  Secondary:   Side Effect Checklist (SEC) - Nasal Irritation   [ Time Frame: Weekly for 6 weeks ]

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

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

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

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

63.  Secondary:   Side Effect Checklist (SEC) - Sore Throat   [ Time Frame: Weekly for 6 weeks ]

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

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

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

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

68.  Secondary:   Side Effect Checklist (SEC) - Uterine Contractions   [ Time Frame: Weekly for 6 weeks ]

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

70.  Secondary:   Side Effect Checklist (SEC) - Weight Loss   [ Time Frame: Weekly for 6 weeks ]

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

72.  Secondary:   Neurocognitive Assessment Battery (MCCB) - Composite Score   [ Time Frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). ]

73.  Secondary:   Neurocognitive Assessment Battery (MCCB) - Attention Vigilance   [ Time Frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). ]

74.  Secondary:   Neurocognitive Assessment Battery (MCCB) - Processing Speed   [ Time Frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). ]

75.  Secondary:   Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving   [ Time Frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). ]

76.  Secondary:   Neurocognitive Assessment Battery (MCCB) - Social Cognition   [ Time Frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). ]

77.  Secondary:   Neurocognitive Assessment Battery (MCCB) - Verbal Learning   [ Time Frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). ]

78.  Secondary:   Neurocognitive Assessment Battery (MCCB) - Visual Learning   [ Time Frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). ]

79.  Secondary:   Neurocognitive Assessment Battery (MCCB) - Working Memory   [ Time Frame: Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). ]

80.  Secondary:   Positive and Negative Affect Schedule (PANAS) - Negative   [ Time Frame: Treatment Week 0 and Week 6 ]

81.  Secondary:   Positive and Negative Affect Schedule (PANAS) - Positive   [ Time Frame: Treatment Week 0 and Week 6 ]

82.  Secondary:   Reactions to Partner   [ Time Frame: Treatment Week 0 and Week 6 ]

83.  Secondary:   Willingness to Interact   [ Time Frame: Treatment Week 0 and Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information