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Study identifier: NCT04580134 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

CLOZAPINE Response in Biotype-1

Condition: Schizophrenia · Schizoaffective Disorder · Bipolar 1 Disorder  ·  Sponsor: University of Texas Southwestern Medical Center

PhasePhase 4
Planned participants524
Who can joinAll sexes, 18 Years to 60 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Asha Philip  ·  214-648-5276  ·  asha.philip@utsouthwestern.edu

Emily McNeil  ·  214-648-1683  ·  emily.mcneil@utsouthwestern.edu

Always discuss trial participation with your own doctor first.

Locations (5)

Hartford HealthcareHartford, Connecticut, United StatesRecruiting
University of GeorgiaAthens, Georgia, United StatesRecruiting
University of ChicagoChicago, Illinois, United StatesRecruiting
Beth Israel Deaconess Medical CenterBoston, Massachusetts, United StatesRecruiting
UT Southwestern Medical CenterDallas, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04580134