CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 76 enrolled
Drug / intervention
Pimozide +1 moredrug
Likely dose
Pimozide 2–8 mg daily (starting 2 mg/day, titrated by 2 mg weekly to max 8 mg/day)AI-extracted
Key inclusion· 6
  • Diagnosis of schizophrenia or schizoaffective disorder per DSM-IV
  • PANSS total score >60
  • PANSS positive subscale score ≥4 on two or more items
  • CGI score ≥4
Key exclusion· 8
  • History of unstable coronary artery disease or congestive heart failure
  • History of long QT syndrome, cardiac arrhythmia, or conduction delay
  • Baseline QTc >0.425 seconds
  • History of neuroleptic malignant syndrome

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

Search/NCT00158223
NCT00158223Phase 4Completed

Pimozide Augmentation of Clozapine in Schizophrenia

Icahn School of Medicine at Mount Sinai·interventional·Posted Sep 12, 2005·Updated Apr 9, 2015

In Brief

A Phase 4 clinical trial evaluating Pimozide and Placebo for Schizophrenia and Psychotic Disorders. Completed, enrolled 76 participants across 3 sites.

Detailed Summary

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

Study Details

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

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2005
Enrollment StartOct 1, 2004
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.8 years ago

Interventions

Pimozidedrug

Each capsule of active treatment will contain 2 mg of pimozide. Dosing will be flexible and will range from a minimum of 2 mg per day to 8 mg per day. Dosing will begin at Week 1 with 1 capsule per day. This will be slowly titrated at a rate of 1 capsule per week to a maximum of 4 capsules depending upon clinical response and side effects.

Placebodrug

Active drug and placebo will be encapsulated in an identical fashion. The placebo capsule will be made to match in appearance and weight. There will be flexible dosing, allowing a minimum of 1 capsule per day to 4 capsules per day, in order to match the dosing range of the active treatment.