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Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Joseph Friedman, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00158223
First received: September 7, 2005
Last updated: April 7, 2015
Last verified: April 2015
Results First Received: September 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Psychotic Disorders
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
Subjects recruited from inpatient and outpatient treatment settings at Mount Sinai Hospital, Pilgrim Psychiatric Center and Manhattan Psychiatric Center in New York.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
16 subjects were excluded during the 4-week symptom stability-screening period before randomization because of withdrawal of consent or a failure to meet inclusion and exclusion criteria. Seven additional subjects were randomized to a haloperidol adjunctive pilot study.

Reporting Groups
  Description
Placebo Participants received encapsulated placebo made to match active drug
Pimozide Participants received pimozide flexible dosing

Participant Flow:   Overall Study
    Placebo   Pimozide
STARTED   28   25 
COMPLETED   23   22 
NOT COMPLETED   5   3 



  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 Participants received encapsulated placebo made to match active drug
Pimozide Participants received pimozide flexible dosing
Total Total of all reporting groups

Baseline Measures
   Placebo   Pimozide   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   25   53 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.4  (8.7)   45.5  (10.2)   44.9  (9.5) 
Gender 
[Units: Participants]
     
Female   8   4   12 
Male   20   21   41 
Treatment Setting 
[Units: Participants]
     
Inpatient   19   15   34 
Outpatient   9   10   19 


  Outcome Measures
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1.  Primary:   Positive Syndrome Scale (PANSS) Total Score   [ Time Frame: Variable change from baseline to week 12 ]

2.  Primary:   Negative Syndrome Scale (PANSS) Total Score   [ Time Frame: Variable change from baseline to week 12 ]

3.  Secondary:   Clinical Global Impression of Change (CGIC)   [ Time Frame: variable change from baseline to week 12 ]


  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
Neither baseline nor follow-up clozapine plasma concentrations were reported. Possible that one or both groups did not have therapeutic baseline clozapine levels and/or had pharmacokinetic interactions with the study drug changing concentrations.


  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: Dr. Joseph I. Friedman
Organization: Icahn School of Medicine at Mount Sinai
phone: 631-761-3607
e-mail: joseph.friedman@mssm.edu


Publications of Results:
Other Publications:

Responsible Party: Joseph Friedman, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00158223     History of Changes
Other Study ID Numbers: GCO 02-0517
R01MH067806 ( US NIH Grant/Contract Award Number )
Study First Received: September 7, 2005
Results First Received: September 3, 2013
Last Updated: April 7, 2015
Health Authority: United States: Federal Government