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Trial record 40 of 64 for:    dry mouth | NIH

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Withdrawn Prior to Study Drug Exposure   1   0   1 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


  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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William Carpenter, Jr.
Organization: Maryland Psychiatric Research Center
phone: 410-402-7101
e-mail: wcarpent@mprc.umaryland.edu



Responsible Party: William Carpenter, University of Maryland
ClinicalTrials.gov Identifier: NCT01012167     History of Changes
Other Study ID Numbers: HP-00044324
1P50MH082999-01 ( U.S. NIH Grant/Contract )
First Submitted: April 28, 2009
First Posted: November 11, 2009
Results First Submitted: May 25, 2016
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017