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RECRUITING
NCT04580134
PHASE4

CLOZAPINE Response in Biotype-1

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

The CLOZAPINE study is designed as a multisite study across 5 sites and is a clinical trial, involving human participants who are prospectively assigned to an intervention. The study will utilize a stringent randomized, double-blinded, parallel group clinical trial design. B2 group will serve as psychosis control with risperidone as medication control. The study is designed to evaluate effect of clozapine on the B1 participants, and the effect that will be evaluated is a biomedical outcome. The study sample will be comprised of individuals with psychosis, including 1) schizophrenia, 2) schizoaffective disorder and 3) psychotic bipolar I disorder. The investigators plan to initially screen and recruit n=524 (from both the existing B-SNIP library and newly-identified psychosis cases, \~50% each) in order to enroll n=320 (B1 and B2) into the RCT.

Official title: Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

524

Start Date

2022-03-01

Completion Date

2026-04-01

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

DRUG

clozapine

Biotype 1 and Biotype 2

DRUG

risperidone

Biotype 1 and Biotype 2

Locations (5)

Hartford Healthcare

Hartford, Connecticut, United States

University of Georgia

Athens, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

UT Southwestern Medical Center

Dallas, Texas, United States