Phase 4
Completed N=53
Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia
Source: ClinicalTrials.gov NCT00158223 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcomePrimary: Positive Syndrome Scale (PANSS) Total Score — -1.05; -1.30 units on a scale
Summary
This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Syndrome Scale (PANSS) Total Score |
-1.05; -1.30 | — |
| PRIMARY Negative Syndrome Scale (PANSS) Total Score |
-1.59; 0.65 | — |
| SECONDARY Clinical Global Impression of Change (CGIC) |
-0.35; -0.15 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of schizophrenia according to DSM-IV criteria
- Any schizoaffective disorder or subtype
- Score greater than 60 on the Positive and Negative Syndrome Scale (PANSS)
- Currently taking clozapine
- Score of four or higher on two or more items from the positive symptom subscale of the PANSS
- Score of 4 or greater on the Clinical Global Impression (CGI) scale
- Clozapine plasma level greater than 378 µg/ml
- Stable dose of clozapine demonstrated to have been associated with a clozapine plasma level greater than 378 µg/ml for at least eight weeks
- Able to read at an 8th grade level or above
Exclusion Criteria
- History of unstable coronary artery disease
- Congestive heart failure
- History of long Q-T syndrome
- History of cardiac arrhythmia
- History of cardiac conduction delay
- Baseline QT correction score greater than 0.425 seconds
- Liver disease
- History of stroke
- History of Neuroleptic Malignant Syndrome
- Hypokalemia
- Hypocalcemia
- Current blindness, deafness, language difficulties, or any other disability which may prevent participation or cooperation in the study
- Current suicidal or homicidal thoughts
- Currently abusing psychoactive substances
- Currently receiving antidepressants, thymoleptics, L-DOPA, buspirone, or antipsychotics other than clozapine (Valproic acid and Divalproex sodium are not criteria for exclusion)
Data sourced from ClinicalTrials.gov (NCT00158223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.