Actively Recruiting
CLOZAPINE Response in Biotype-1
Led by University of Texas Southwestern Medical Center · Updated on 2026-05-11
524
Participants Needed
5
Research Sites
269 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
CLOZAPINE Response in Biotype-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- All genders and races
- Able to provide written informed consent
- Able to read, speak, and understand English
- Medically stable
- Diagnosed with schizophrenia, schizoaffective disorder, or bipolar I disorder with psychotic features according to DSM-IV criteria
- PANSS total score of 70 or higher
- At least one PANSS Positive Subscale item scored 5 or more, or two items scored 4 or more
- Normal baseline absolute neutrophil count (ANC above 1500/mm3)
You will not qualify if you...
- Premorbid intellectual ability below 70 (based on WRAT-4 Word Reading subtest)
- Alcohol or substance abuse in the past 1 month
- Substance dependence in the past 3 months
- Neurological disorders such as seizure disorder, stroke, or traumatic brain injury with loss of consciousness of 30 minutes or more
- Severe medical conditions affecting the central nervous system (e.g., decompensated cardiovascular disorder, AIDS)
- Use of medications affecting EEG or strong CYP 1A2 inhibitors or strong CYP 3A4 inducers that cannot be stopped safely
- Vulnerable populations including pregnant, nursing, or incarcerated individuals
- Unwillingness to use reliable contraception
- History of neuroleptic malignant syndrome
- Previous treatment with clozapine or long-acting injectable antipsychotics within specified time frames
- Intolerable side effects or failed trial of clozapine or risperidone at adequate doses
- History of drug reaction with eosinophilia and systemic symptoms syndrome (DRESS/DIHS)
- High risk of suicide or homicidal ideation that precludes outpatient care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Hartford Healthcare
Hartford, Connecticut, United States, 06106
Actively Recruiting
2
University of Georgia
Athens, Georgia, United States, 30602
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60615
Actively Recruiting
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
A
Asha Philip
CONTACT
E
Emily McNeil
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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