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CLOZAPINE Response in Biotype-1
Sponsor: University of Texas Southwestern Medical Center
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
clozapine
Biotype 1 and Biotype 2
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