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

Phase 4 Completed 76 enrolled Icahn School of Medicine at Mount Sinai National Institute of Mental Health (NIMH) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2004-10
Primary completion: 2009-02
Completion: 2009-02

Outcome

Missed primary endpoint

paper pimozide was found to be no better than placebo in combination with clozapine at reducing Positive and Negative Syndrome Scale total PMID 21346734 ↗

Publications

Background Friedman J, Ault K, Powchik P. Pimozide augmentation for the treatment of schizophrenic patients who are partial responders to clozapine. Biol Psychiatry. 1997 Sep 15;42(6):522-3. doi: 10.1016/S0006-3223(97)00227-8. No abstract available.
Results Friedman JI, Lindenmayer JP, Alcantara F, Bowler S, Parak M, White L, Iskander A, Parrella M, Adler DN, Tsopelas ND, Tsai WY, Novakovic V, Harvey PD, Davis KL, Kaushik S. Pimozide augmentation of clozapine inpatients with schizophrenia and schizoaffective disorder unresponsive to clozapine monotherapy. Neuropsychopharmacology. 2011 May;36(6):1289-95. doi: 10.1038/npp.2011.14. Epub 2011 Feb 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pimozide	Small molecule	2 mg	—
Subject	Pimozide	Small molecule	8 mg	—