Trial · NCT00374244
Efficacy of Pimozide Augmentation for Clozapine Partial Response
NCT00374244, Phase 2, Completed, Yale University; results first posted 2016-03-04
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Efficacy of Pimozide Augmentation for Clozapine Partial Response. Trials, record NCT00374244. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00374244
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Pimozide Augmentation for Clozapine Partial Response
- NCT number
- NCT00374244
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Schizophrenia
- Interventions
- Pimozide, placebo
- First posted
- 2006-09-11
- Last updated
- 2016-03-04
- Results first posted
- 2016-03-04
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Brief Psychiatric Rating Scale (BPRS) Total Score | Baseline | The Brief Psychiatric Rating Scale (BPRS) is an 18-item instrument. The items are anchored on a 7-point scale (higher rating: greater severity). Total scores range from 18 to 126 (higher score: greater severity). The instrument covers areas including: somatic concerns, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement and disorientation. |
| Primary | Brief Psychiatric Rating Scale (BPRS) Total Score | Endpoint (12 weeks) | The Brief Psychiatric Rating Scale (BPRS) is an 18-item instrument. The items are anchored on a 7-point scale (higher rating: greater severity). Total scores range from 18 to 126 (higher score: greater severity). The instrument covers areas including: somatic concerns, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement and disorientation. |
| Primary | Scale for the Assessment of Negative Symptoms (SANS) | baseline | The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia. The scale has 25 items (20 individual and 5 global) rated on scale of 0-5 (higher rating: greater severity). SANS is split into 5 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). Domains include: Affective Flattening or Blunting, Alogia, Avolition - Apathy, Anhedonia - Asociality, Attention. The total range of the SANS is from 0 to 120. |
| Primary | Scale for the Assessment of Negative Symptoms (SANS) | Endpoint (12 weeks) | The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia. The scale has 25 items (20 individual and 5 global) rated on scale of 0-5 (higher rating: greater severity). SANS is split into 5 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). Domains include: Affective Flattening or Blunting, Alogia, Avolition - Apathy, Anhedonia - Asociality, Attention. The total range of the SANS is from 0 to 120. |
| Secondary | CGI Severity of Illness Scale (CGI-S) | baseline | CGI Severity of Illness Scale (CGI-S) assesses severity of illness on 1-7 scale. Clinicians' experience is used to gauge the severity of illness from 'normal' (value=1) to 'among the most extremely ill patients' (value=7). The higher rating correlates with more severely ill. |
| Secondary | CGI Severity of Illness Scale (CGI-S) | Endpoint (12 weeks) | CGI Severity of Illness Scale (CGI-S) assesses severity of illness on 1-7 scale. Clinicians' experience is used to gauge the severity of illness from 'normal' (value=1) to 'among the most extremely ill patients' (value=7). The higher rating correlates with more severely ill. |
| Secondary | CGI Improvement Scale (CGI-I) | Endpoint (12 weeks) | CGI Improvement Scale (CGI-I) higher rating correlates with worsening of condition (vs. improvement with lower rating). The CGI-I is scored from 1 to 7 where 1 = 'very much improved' and 7 = 'very much worse'. Clinicians are asked to rate total improvement in the following manner: "...in your judgement, it is due entirely to drug treatment. Compared to his condition at admission to the project, how much has he changed?" |
| Secondary | Verbal Fluency | Baseline | Verbal fluency was measured using the Controlled Word Association Test (COWAT). There is no range for this measure, as it is not a scale. The subjects can generate as many new words as they can, so there is no maximum. The greater the number of words one generates indicates better performance. |
| Secondary | Verbal Fluency | Endpoint (12 weeks) | Verbal fluency was measured using the Controlled Word Association Test (COWAT). There is no range for this measure, as it is not a scale. The subjects can generate as many new words as they can, so there is no maximum. The greater the number of words one generates indicates better performance. |
| Secondary | QTc | Baseline | The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart. ECG machines calculate a corrected QT (QTc). QTc is the corrected QT interval in the EKG. Normal range is from 430-470ms. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Brief Psychiatric Rating Scale (BPRS) Total Score | Baseline | Subjects were analyzed intent to treat. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Brief Psychiatric Rating Scale (BPRS) Total Score | Endpoint (12 weeks) | Subjects were analyzed intent to treat. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | CGI Severity of Illness Scale (CGI-S) | baseline | Analyzes intent to treat. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | CGI Severity of Illness Scale (CGI-S) | Endpoint (12 weeks) | Analyzed intent to treat. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | CGI Improvement Scale (CGI-I) | Endpoint (12 weeks) | Analyzed intent to treat. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Scale for the Assessment of Negative Symptoms (SANS) | baseline | Analyzed intent to treat. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Scale for the Assessment of Negative Symptoms (SANS) | Endpoint (12 weeks) | Analyzed intent to treat. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Verbal Fluency | Baseline | Intent to Treat Analysis | words | MEAN |
| SECONDARY | Verbal Fluency | Endpoint (12 weeks) | Intent to Treat Analysis | words | MEAN |
| SECONDARY | QTc | Baseline | Intention to Treat | ms | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Brief Psychiatric Rating Scale (BPRS) Total Score | Placebo Pimozide | 44.1 | Standard Error 2.0 | units on a scale | |
| Brief Psychiatric Rating Scale (BPRS) Total Score | Active Pimozide | 44.3 | Standard Error 2.0 | units on a scale | |
| Brief Psychiatric Rating Scale (BPRS) Total Score | Placebo Pimozide | 37.9 | Standard Error 2.1 | units on a scale | |
| Brief Psychiatric Rating Scale (BPRS) Total Score | Active Pimozide | 39.6 | Standard Error 2.1 | units on a scale | |
| CGI Severity of Illness Scale (CGI-S) | Placebo Pimozide | 4.1 | Standard Error 0.5 | units on a scale | |
| CGI Severity of Illness Scale (CGI-S) | Active Pimozide | 4.0 | Standard Error 0.9 | units on a scale | |
| CGI Severity of Illness Scale (CGI-S) | Placebo Pimozide | 3.9 | Standard Error 0.8 | units on a scale | |
| CGI Severity of Illness Scale (CGI-S) | Active Pimozide | 3.9 | Standard Error 0.5 | units on a scale | |
| CGI Improvement Scale (CGI-I) | Placebo Pimozide | 2.8 | Standard Error 1.0 | units on a scale | |
| CGI Improvement Scale (CGI-I) | Active Pimozide | 3.4 | Standard Error 0.5 | units on a scale |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Pimozide | 14 | |
| Overall Study | STARTED | Active Pimozide | 14 | |
| Overall Study | COMPLETED | Placebo Pimozide | 14 | |
| Overall Study | COMPLETED | Active Pimozide | 14 | |
| Overall Study | NOT COMPLETED | Placebo Pimozide | 0 | |
| Overall Study | NOT COMPLETED | Active Pimozide | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | QTc Prolongation | Cardiac disorders | Placebo Pimozide | 1 | 14 | 1 |
| other | QTc Prolongation | Cardiac disorders | Active Pimozide | 1 | 14 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Pimozide | ||
| Total, all-cause mortality | Active Pimozide | ||
| Total, other adverse events | Placebo Pimozide | 1 | 14 |
| Total, other adverse events | Active Pimozide | 1 | 14 |
| Total, serious adverse events | Placebo Pimozide | 0 | 14 |
| Total, serious adverse events | Active Pimozide | 0 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Active Pimozide vs Placebo Pimozide: serious adverse events |
Source Trial comparisons
Tests8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Task Switching Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
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/NCT00374244
GET https://conductscience.org/api/trials/v1/NCT00374244/registered?page=2