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Clinical trialNCT04580134RecruitingPhase 4Interventional

CLOZAPINE Response in Biotype-1

SponsorUniversity of Texas Southwestern Medical CenterEnrollment524Bipolar 1 DisorderSchizoaffective DisorderSchizophrenia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Hartford Healthcare

    Hartford, Connecticut, United States

    Recruiting
  • University of Georgia

    Athens, Georgia, United States

    Recruiting
  • University of Chicago

    Chicago, Illinois, United States

    Recruiting
  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States

    Recruiting
  • Ut Southwestern Medical Center

    Dallas, Texas, United States

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Mar 2022
Primary completion
30 Apr 2027
Completion
30 Apr 2027
Last update posted
11 May 2026
Registered enrollment
524
Registry id
NCT04580134

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.