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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: Recruiting Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by University of Texas Southwestern Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The change in the PANSS total score from the clinical trial baseline (W4) to the end of treatment (W18) will be a primary outcome measure. We predict that B1/clozapine will show a significantly larger change in the PANSS score from W4 to W18, compared to B1/risperidone, B2/clozapine and B2/risperidone. We will also examine the patterns of change in the PANSS score during the 'stable treatment' phase (W10-W18), across the same study groups. A mixed-effect repeated-measures ANCOVA \[2(Biotypes) ×
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 524 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 4 |
What NCT04580134 shows while recruiting
NCT04580134 is an interventional study that assigns participants to a tested intervention. The registered 524 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (141% higher).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04580134's enrollment target sits among peer trials
524 36th of 315 higher than 280 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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