RecruitingPhase 4NCT04580134

CLOZAPINE Response in Biotype-1

Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine)


Sponsor

University of Texas Southwestern Medical Center

Enrollment

524 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests the medication clozapine in people with a specific biological profile (called Biotype-1) of psychotic illness, which includes schizophrenia, schizoaffective disorder, and bipolar disorder with psychotic features. The goal is to see whether clozapine works especially well for this subgroup defined by brain wave patterns. **You may be eligible if...** - You are 18–60 years old - You have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar I disorder with psychotic features - You have significant psychotic symptoms (as measured by the PANSS scale) - You have a normal white blood cell count - You are medically stable - You can read, speak, and understand English **You may NOT be eligible if...** - You have a history of substance abuse in the past month or dependence in the past 3 months - You have a seizure disorder, stroke, or serious brain injury - You have a severe heart condition or AIDS - You have previously taken clozapine or had bad reactions to it - You are pregnant or breastfeeding - You are taking certain medications that affect brain activity (like lithium, anticonvulsants, or benzodiazepines) that cannot safely be stopped Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGclozapine

Biotype 1 and Biotype 2

DRUGrisperidone

Biotype 1 and Biotype 2


Locations(5)

Hartford Healthcare

Hartford, Connecticut, United States

University of Georgia

Athens, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

UT Southwestern Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04580134


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