CLOZAPINE Response in Biotype-1
Condition(s) studied
Investigational drug(s) / intervention(s)
clozapine: Biotype 1 and Biotype 2
risperidone: Biotype 1 and Biotype 2
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.
Eligibility
Primary outcome measure(s)
- Change in the PANSS total score — Week 4, Week 10 and Week 18
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 \[2(Biotypes) × 2(clozapine/risperidone) × 2(time points\] will be used. We also predict that the reduction in the PANSS scores will correlate with increased IEA in B1/clozapine but not in B1/risperidone, B2/clozapine or B2/risperidone. Multivariate prediction models will be used.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Hartford Healthcare | Hartford | Connecticut | Recruiting |
| University of Georgia | Athens | Georgia | Recruiting |
| University of Chicago | Chicago | Illinois | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04580134 on ClinicalTrials.gov ↗ ← All trials in Israel