Trial · NCT00158223
Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia
NCT00158223, Phase 4, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2015-04-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia. Trials, record NCT00158223. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00158223
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia
- NCT number
- NCT00158223
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 76 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- Schizophrenia, Psychotic Disorders
- Interventions
- Pimozide, Placebo
- First posted
- 2005-09-12
- Last updated
- 2015-04-09
- Results first posted
- 2015-04-09
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Positive Syndrome Scale (PANSS) Total Score | Variable change from baseline to week 12 | 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. |
| Primary | Negative Syndrome Scale (PANSS) Total Score | Variable change from baseline to week 12 | 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. |
| Secondary | Clinical Global Impression of Change (CGIC) | variable change from baseline to week 12 | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Positive Syndrome Scale (PANSS) Total Score | Variable change from baseline to week 12 | units on a scale | MEAN | |
| SECONDARY | Clinical Global Impression of Change (CGIC) | variable change from baseline to week 12 | units on a scale | MEAN | |
| PRIMARY | Negative Syndrome Scale (PANSS) Total Score | Variable change from baseline to week 12 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Positive Syndrome Scale (PANSS) Total Score | Placebo | -1.05 | Standard Deviation 2.98 | units on a scale | |
| Positive Syndrome Scale (PANSS) Total Score | Pimozide | -1.30 | Standard Deviation 2.56 | units on a scale | |
| Clinical Global Impression of Change (CGIC) | Placebo | -0.35 | Standard Deviation 0.57 | units on a scale | |
| Clinical Global Impression of Change (CGIC) | Pimozide | -0.15 | Standard Deviation 4.97 | units on a scale | |
| Negative Syndrome Scale (PANSS) Total Score | Placebo | -1.59 | Standard Deviation 4.46 | units on a scale | |
| Negative Syndrome Scale (PANSS) Total Score | Pimozide | 0.65 | Standard Deviation 4.65 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 28 | |
| Overall Study | STARTED | Pimozide | 25 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | COMPLETED | Pimozide | 22 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Pimozide | 3 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Severe EPS | Nervous system disorders | Placebo | 0 | 28 | 0 |
| other | Severe EPS | Nervous system disorders | Pimozide | 1 | 25 | 1 |
| other | delirium | Renal and urinary disorders | Placebo | 0 | 28 | 0 |
| other | delirium | Renal and urinary disorders | Pimozide | 1 | 25 | 1 |
| other | bleeding | Gastrointestinal disorders | Placebo | 0 | 28 | 0 |
| other | bleeding | Gastrointestinal disorders | Pimozide | 1 | 25 | 1 |
| other | psychotic symptoms | Psychiatric disorders | Placebo | 2 | 28 | 2 |
| other | psychotic symptoms | Psychiatric disorders | Pimozide | 0 | 25 | 0 |
| other | bigeminy | Cardiac disorders | Placebo | 1 | 28 | 1 |
| other | bigeminy | Cardiac disorders | Pimozide | 0 | 25 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Pimozide | ||
| Total, other adverse events | Placebo | 5 | 28 |
| Total, other adverse events | Pimozide | 3 | 25 |
| Total, serious adverse events | Placebo | 0 | 28 |
| Total, serious adverse events | Pimozide | 0 | 25 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH067806 | Pimozide Augmentation of Clozapine in Schizophrenia | FRIEDMAN, JOSEPH IRWIN | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL INSTITUTE OF MENTAL HEALTH | 2004 to 2007 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Pimozide vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00158223
GET https://conductscience.org/api/trials/v1/NCT00158223/registered