Schizophrenia Clinical Trial
Official title:
Pimozide Augmentation of Clozapine in Schizophrenia
This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.
A significant number of schizophrenics exhibit partial or no response to typical
antipsychotic medications. Clozapine has been shown to be more effective in treating
schizophrenia than typical antipsychotic drugs. However, only an estimated 30% to 60% of
people who are unresponsive to treatment with typical antipsychotics will respond to
treatment with clozapine. Taking clozapine with pimozide, an antipsychotic drug, can
increase clozapine's effects. However, sufficient research on this approach has not yet been
performed. This study will assess the effectiveness of pimozide in enhancing the effects of
clozapine in the treatment of schizophrenia.
Participants in this double-blind study will receive a stable dose of clozapine for eight
weeks prior to enrollment. For the first 4 weeks following enrollment, baseline measurements
will be taken. Once a week, participants will report to the study site, where symptom
severity, cognitive ability, and functional status, including reading level, will be
assessed. In addition, participants will receive a standard medical examination, which will
include blood tests and an EKG. Upon completion of this initial phase, participants will be
randomly assigned to one of two treatment groups: clozapine combined with pimozide; or
clozapine combined with placebo. This phase will last for 12 weeks. Study visits will
continue to occur weekly, and will be used to re-assess the measurements obtained during
baseline. In addition, participants will have an EKG at each study visit for the first 4
weeks of treatment. All baseline measurements will be repeated in Week 12.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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