Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia
Completed · Phase 4 · Has a placebo group
Conditions studied: Schizophrenia, Psychotic Disorders
In brief
This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.
Key facts
- Study ID
- NCT00158223
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 76
- Starts
- 2004-10-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2015-04-09
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Manhattan Psychiatric Center — New York, New York, United States
- Pilgrim Psychiatric Center — W. Brentwood, New York, United States
Full record on ClinicalTrials.gov
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