CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Pimozide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00374244
NCT00374244Phase 2Completed

Efficacy of Pimozide Augmentation for Clozapine Partial Response

Yale University·interventional·Posted Sep 11, 2006·Updated Mar 4, 2016

In Brief

A Phase 2 clinical trial evaluating Pimozide and placebo for Schizophrenia. Completed, enrolled 28 participants across 2 sites.

Detailed Summary

This is a 12 week outpatient study for patients with schizophrenia who are on Clozapine, but continue to experience symptoms. The purpose of this project is to find out if small doses of pimozide (an antipsychotic medication, taken by mouth) will be helpful in reducing symptoms (such as hearing voices, having trouble in organizing your thoughts, lack of interest in life events and social activities), compared to placebo (an inactive substance, "sugar pill"), when added to clozapine in patients with schizophrenia. The participant will be asked to come in once a week to meet with the research staff and study doctor. The participant will continue to see your regular clinician during this study for all normal appointments. The participant will remain on your current medications throughout the study. During the study you will be randomly selected to be put on a small dose of Pimozide or placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2006
Enrollment StartJan 1, 2004
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 19.8 years ago

Interventions

Pimozidedrug

half of the subjects are randomized to the active drug group

placebodrug

half of the subjects are randomized to placebo group