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Efficacy of Pimozide Augmentation for Clozapine Partial Response

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00374244
First received: September 7, 2006
Last updated: February 4, 2016
Last verified: February 2016
Results First Received: January 10, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Pimozide
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This clinical trial was conducted at the outpatient clinics of the West Haven VA, Connecticut Mental Health Center of Yale Department of Psychiatry, and the Zucker-Hillside Hospital of Long Island Jewish Health Care System, and approved by the respective Institutional Review Boards.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, a stable dose of clozapine for the past 2 weeks with a blood level of at least 350 ng/ml was targeted. Subjects were stratified as to whether they were receiving psychoactive medications such as mood stabilizers, to ensure that about equal numbers of subjects were randomized based on this treatment profile.

Reporting Groups
  Description
Placebo Pimozide Half of the subjects were randomized to placebo group.
Active Pimozide Half of the subjects are randomized to the active drug.

Participant Flow:   Overall Study
    Placebo Pimozide   Active Pimozide
STARTED   14   14 
COMPLETED   14   14 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Placebo Pimozide Half of the subjects were randomized to placebo group.
Active Pimozide Half of the subjects are randomized to the active drug.
Total Total of all reporting groups

Baseline Measures
   Placebo Pimozide   Active Pimozide   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   14   28 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.5  (2.8)   44.3  (2.0)   43.0  (9.0) 
Gender 
[Units: Participants]
     
Female   4   4   8 
Male   10   10   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Brief Psychiatric Rating Scale (BPRS) Total Score   [ Time Frame: Baseline ]

2.  Primary:   Brief Psychiatric Rating Scale (BPRS) Total Score   [ Time Frame: Endpoint (12 weeks) ]

3.  Primary:   Scale for the Assessment of Negative Symptoms (SANS)   [ Time Frame: baseline ]

4.  Primary:   Scale for the Assessment of Negative Symptoms (SANS)   [ Time Frame: Endpoint (12 weeks) ]

5.  Secondary:   CGI Severity of Illness Scale (CGI‐S)   [ Time Frame: baseline ]

6.  Secondary:   CGI Severity of Illness Scale (CGI‐S)   [ Time Frame: Endpoint (12 weeks) ]

7.  Secondary:   CGI Improvement Scale (CGI‐I)   [ Time Frame: Endpoint (12 weeks) ]

8.  Secondary:   Verbal Fluency   [ Time Frame: Baseline ]

9.  Secondary:   Verbal Fluency   [ Time Frame: Endpoint (12 weeks) ]

10.  Secondary:   QTc   [ Time Frame: Baseline ]

11.  Secondary:   QTc   [ Time Frame: Endpoint (12 weeks) ]

12.  Secondary:   Processing Speed   [ Time Frame: Baseline ]

13.  Secondary:   Processing Speed   [ Time Frame: Endpoint (12 weeks) ]

14.  Secondary:   Verbal Learning and Memory: List A   [ Time Frame: Baseline ]

15.  Secondary:   Verbal Learning and Memory: List A   [ Time Frame: Endpoint (12 weeks) ]

16.  Secondary:   Verbal Learning and Memory: List B   [ Time Frame: Baseline ]

17.  Secondary:   Verbal Learning and Memory: List B   [ Time Frame: Endpoint (12 weeks) ]

18.  Secondary:   Trail Making Test: Trail A   [ Time Frame: Baseline ]

19.  Secondary:   Trail Making Test: Trail A   [ Time Frame: Endpoint (12 weeks) ]

20.  Secondary:   Trail Making Test: Trail B   [ Time Frame: Baseline ]

21.  Secondary:   Trail Making Test: Trail B   [ Time Frame: Endpoint (12 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Handan Gunduz-Bruce MD
Organization: Yale University School of Medicine, Dept of Psychiatry
phone: (203) 932-5711 ext 4130
e-mail: handan.gunduz-bruce@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00374244     History of Changes
Other Study ID Numbers: 02T-251
Study First Received: September 7, 2006
Results First Received: January 10, 2013
Last Updated: February 4, 2016
Health Authority: United States: Institutional Review Board