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Trial record 2 of 12 for:    pimozide

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

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ClinicalTrials.gov Identifier: NCT00158223
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : April 9, 2015
Last Update Posted : April 9, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Joseph Friedman, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Psychotic Disorders
Interventions Drug: Pimozide
Drug: Placebo
Enrollment 76
Recruitment Details 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 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.
Arm/Group Title Placebo Pimozide
Hide Arm/Group Description Participants received encapsulated placebo made to match active drug Participants received pimozide flexible dosing
Period Title: Overall Study
Started 28 25
Completed 23 22
Not Completed 5 3
Arm/Group Title Placebo Pimozide Total
Hide Arm/Group Description Participants received encapsulated placebo made to match active drug Participants received pimozide flexible dosing Total of all reporting groups
Overall Number of Baseline Participants 28 25 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 25 participants 53 participants
44.4  (8.7) 45.5  (10.2) 44.9  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 53 participants
Female
8
  28.6%
4
  16.0%
12
  22.6%
Male
20
  71.4%
21
  84.0%
41
  77.4%
Treatment Setting  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 25 participants 53 participants
Inpatient 19 15 34
Outpatient 9 10 19
1.Primary Outcome
Title Positive Syndrome Scale (PANSS) Total Score
Hide Description Severity of positive schizophrenic symptoms The Positive Syndrome Scale of the PANSS is comprised of seven items measuring positive such symptoms such as hallucinations, delusions, grandiosity, etc. Each item is scored on a 7 point scale of that particular symptom's severity, ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The PANSS Positive Subscale seven items has a range of a summed score from 7 (absent) to 49 (extreme psychopathology). Therefore, the higher the score, the more severe the symtpoms.
Time Frame Variable change from baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Pimozide
Hide Arm/Group Description:
Participants received encapsulated placebo made to match active drug
Participants received pimozide flexible dosing
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.05  (2.98) -1.30  (2.56)
2.Primary Outcome
Title Negative Syndrome Scale (PANSS) Total Score
Hide Description Severity of negative schizophrenic symptoms, The Negative Syndrome scale is compromised of seven items, each scored on severity with numeric assignments ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The items which comprise the Negative Syndrome Scale of the PANSS measure things such as emotional withdrawal, apathy, difficulty in abstract thinking, etc. The seven items which comprise the PANSS Negative Subscale has an aggregate range of 7 (absent) to 49 (extreme psychopathology), a higher score indicating more severe symptoms.
Time Frame Variable change from baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Pimozide
Hide Arm/Group Description:
Participants received encapsulated placebo made to match active drug
Participants received pimozide flexible dosing
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.59  (4.46) 0.65  (4.65)
3.Secondary Outcome
Title Clinical Global Impression of Change (CGIC)
Hide Description The Clinical Global Impression-improvement (CGI-improvement) scale is a research rating tool, developed for use in NIMH-sponsored clinical trials provides a brief assessment of the clinician's view of the patient's overall clinical improvement prior to and after initiating a study medication. The CGI-change is rated on a seven point scale ranging from 1= very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment. Therefore, a lower score indicates more improvement in symptoms over time.
Time Frame variable change from baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Pimozide
Hide Arm/Group Description:
Participants received encapsulated placebo made to match active drug
Participants received pimozide flexible dosing
Overall Number of Participants Analyzed 23 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.35  (0.57) -0.15  (4.97)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Pimozide
Hide Arm/Group Description Participants received encapsulated placebo made to match active drug Participants received pimozide flexible dosing
All-Cause Mortality
Placebo Pimozide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Pimozide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Pimozide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/28 (17.86%)      3/25 (12.00%)    
Cardiac disorders     
bigeminy   1/28 (3.57%)  1 0/25 (0.00%)  0
hypotension   1/28 (3.57%)  1 0/25 (0.00%)  0
Gastrointestinal disorders     
bleeding  [1]  0/28 (0.00%)  0 1/25 (4.00%)  1
Nervous system disorders     
Severe EPS   0/28 (0.00%)  0 1/25 (4.00%)  1
Psychiatric disorders     
psychotic symptoms   2/28 (7.14%)  2 0/25 (0.00%)  0
Renal and urinary disorders     
delirium   0/28 (0.00%)  0 1/25 (4.00%)  1
Social circumstances     
withdrew consent   1/28 (3.57%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
exacerbation of hemorrhoidal bleeding
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Joseph I. Friedman
Organization: Icahn School of Medicine at Mount Sinai
Phone: 631-761-3607
EMail: joseph.friedman@mssm.edu
Layout table for additonal information
Responsible Party: Joseph Friedman, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00158223     History of Changes
Other Study ID Numbers: GCO 02-0517
R01MH067806 ( U.S. NIH Grant/Contract )
First Submitted: September 7, 2005
First Posted: September 12, 2005
Results First Submitted: September 3, 2013
Results First Posted: April 9, 2015
Last Update Posted: April 9, 2015