Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine)
Status:
Not yet recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborators:
Beth Israel Deaconess Medical Center Hartford Hospital National Institute of Mental Health (NIMH) University of Chicago University of Georgia