Status:
RECRUITING
Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Two-hundred and eighty individuals with schizophrenia who have a recent history of violent acts will be randomized in this 2-arm, parallel-group, 24-week, open-label, 7-site clinical trial to examine ...
Detailed Description
This is a single-blind, open-label, randomized, active comparator (TAU) controlled clinical trial to examine the effects of clozapine vs. TAU on the risk for violent acts as measured by the MacArthur ...
Eligibility Criteria
Inclusion
- Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of schizophrenia or schizoaffective disorder by the Structured Clinical Interview for DSM-5 (SCID-5)
- commission of a minor or serious act of violence as measured by the MCVI in the last six months
- willing and able to provide informed consent
- medically stable in judgment of physician providing study treatment
- appropriate for treatment with either clozapine or TAU, i.e., that there is clinical equipoise between the two treatment options. Individuals who are currently medication free or on any antipsychotic, with the exception of clozapine or long-acting injectable medication with a dosing interval of more than 30 days will be eligible
Exclusion
- An unstable of serious medical or neurological condition including a myeloproliferative disorder or condition that surprises the bone marrow
- A history of intolerance/allergy to clozapine (e.g., agranulocytosis, small bowel obstruction, or myocarditis)
- A history of intellectual impairment
- pregnant or lactating women; women who are able to become pregnant but who are not willing to sue effective methods of birth control
- Individuals who score a 3, 4, or 5 within the previous month on the suicidal ideation section of the Columbia Suicide Severity Rating Scale (CSSRS), have any suicidal behavior (not including Not Suicidal Self Injury) within the previous 3 months, or are, in the opinion of the investigator, at too high of a risk for suicide to be safety treated in a randomized trial in which they may not be treated with clozapine
- Documented intolerance to or lack of any therapeutic benefit with clozapine after a full trial
Key Trial Info
Start Date :
March 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT05208190
Start Date
March 17 2022
End Date
February 28 2027
Last Update
November 26 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, Los Angeles
Los Angeles, California, United States, 90024
2
Augusta University Research Institute, Inc.
Augusta, Georgia, United States, 30912
3
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
4
NYU Langone Medical Center
New York, New York, United States, 10016