Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Clozapine; Pimozide

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)