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NCT04580134 · ClinicalTrials.gov registry record · Phase 4

CLOZAPINE Response in Biotype-1

A Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by University of Texas Southwestern Medical Center.

Recruiting
Registry status
Phase 4
Development phase
524
Enrollment target
5
Study locations

NCT04580134 is a Phase 4 study of Schizophrenia and Schizoaffective Disorder that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 524 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (141% higher). The trial reports 5 study locations across 5 states.

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The verdict

NCT04580134, a Phase 4 study of Schizophrenia and Schizoaffective Disorder, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.

RECRUITING
Registry status
Phase 4
Development phase
524 participants
Enrollment target
5
Study locations

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 Studied

Schizophrenia Schizoaffective Disorder Bipolar 1 Disorder

Interventions

  • DRUG clozapine
  • DRUG risperidone

Study Locations (5)

Connecticut

  • Hartford Healthcare - Hartford

Georgia

  • University of Georgia - Athens

Illinois

  • University of Chicago - Chicago

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston

Texas

  • UT Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 524 participants
Start Date 2022-03-01
Est. Completion 2026-04-01
Phase Phase 4

Sponsor

University of Texas Southwestern Medical Center

837 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04580134

The ClinicalTrials.gov registry entry for NCT04580134 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 524 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (141% higher). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which clozapine is the first listed.

NCT04580134 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Connecticut, Georgia, Illinois.

Frequently Asked Questions

What is clinical trial NCT04580134 about?

NCT04580134 is a clinical study titled "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 psy...

What is the current status of trial NCT04580134?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 524 participants. The study started on 2022-03-01. Estimated completion is 2026-04-01.

What conditions does trial NCT04580134 study?

This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder, Bipolar 1 Disorder.

What interventions are being tested in trial NCT04580134?

The interventions under investigation include: clozapine (DRUG), risperidone (DRUG).

Who is sponsoring clinical trial NCT04580134?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04580134 being conducted?

This trial has 5 study locations across Connecticut, Georgia, Illinois, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.