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

PHASE4CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

February 28, 2009

Study Completion Date

February 28, 2009

Conditions
SchizophreniaPsychotic Disorders
Interventions
DRUG

Pimozide

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.

DRUG

Placebo

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.

Trial Locations (3)

10029

Icahn School of Medicine at Mount Sinai, New York

10035

Manhattan Psychiatric Center, New York

11717

Pilgrim Psychiatric Center, W. Brentwood

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Icahn School of Medicine at Mount Sinai

OTHER

NCT00158223 - Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia | Biotech Hunter | Biotech Hunter