CLOZAPINE Response in Biotype-1

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.

NCT Number	NCT04580134
Lead Sponsor	University of Texas Southwestern Medical Center Collaborators: National Institute of Mental Health (NIMH), Beth Israel Deaconess Medical Center, Hartford Hospital, University of Georgia, University of Chicago
Conditions	Schizophrenia, Schizoaffective Disorder, Bipolar 1 Disorder
Enrollment	524 participants
Start Date	2022-03-01
Primary Completion	2027-04-30 (estimated)
Study Completion	2027-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-05-11