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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05208190
Other study ID # I20-02054
Secondary ID 1R01MH120317-01A
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 17, 2022
Est. completion date February 28, 2027

Study information

Verified date March 2023
Source New York State Psychiatric Institute
Contact Ragy Girgis
Phone 646-774-5553
Email ragy.girgis@nyspi.columbia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 the effects of treatment with clozapine vs antipsychotic treatment as usual (TAU) for reducing the risk of violent acts in real-world settings


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 Community Violence Interview (MCVI) and to examine the effects of clozapine vs. TAU on the Excitement Factor of the PANSS. Adults age 18-65 with schizophrenia or schizoaffective disorder who have committed a violent act within 6 months and are appropriate for treatment with clozapine or TAU will receive treatment for 24 weeks which will be naturalistically administered. Participants will also participate in assessments and appropriate medical monitoring which will include blood draws, pharmacokinetic blood samples, and physical exams, etc. Cox proportional hazards survival modeling will be used to test the association between treatment group and time until first violent act after randomization (i.e., number of weeks form randomization to violent act).


Recruitment information / eligibility

Status Recruiting
Enrollment 280
Est. completion date February 28, 2027
Est. primary completion date January 23, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design


Intervention

Drug:
Clozapine
treatment will occur naturalistically, as per standard clinical guidelines
treatment as usual
naturalistic treatment with any other antipsychotic medication except clozapine

Locations

Country Name City State
United States Augusta University Research Institute, Inc. Augusta Georgia
United States University of Maryland School of Medicine Baltimore Maryland
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States University of California, Los Angeles Los Angeles California
United States Manhattan Psychiatric Center New York New York
United States New York State Psychiatric Institute New York New York
United States NYU Langone Medical Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Interventions to Prevent Violence examine the effects of clozapine vs TAU on interventions to prevent violence based on a querying clinicians treating patients about interventions to prevent violence at weeks 4, 8, 16 and 24 Randomization to end of treatment (24 weeks)
Primary Effectiveness outcome: Violent acts violent acts as measured by the MacArthur Community Violence Interview Time to violent act from randomization to treatment completion (24 weeks)
Primary Target engagement outcome: Excitement Factor of the Positive and Negative Syndrome Scale (PANSS) a composite of the scores of excitement, uncooperativeness, poor impulse control, and hostility) Randomization to end of study treatment (24 weeks)
Secondary Effect on aggression examine the effects of clozapine vs TAU on aggression as measured by the Point Subtraction Aggression Paradigm Randomization to end of treatment (24 weeks)
Secondary Positive symptoms and substance use explore effects of clozapine vs TAU on the positive symptom sub scale of the PANSS and alcohol and illicit substance use, how these effects influence the risk for violent acts, and the degree to which clozapine's effects on the Excitement Factor of the PANSS are independent of its effects on total positive symptoms and substance use. Randomization to end of treatment (24 weeks)
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