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CLOZAPINE Response in Biotype-1

NCT04580134 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

clozapine

Biotype 1 and Biotype 2

DRUG

risperidone

Biotype 1 and Biotype 2

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Hartford Hospital

    collaborator OTHER

  • University of Georgia

    collaborator OTHER

  • University of Chicago

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Carol Tamminga, M.D. · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04580134 on ClinicalTrials.gov