RECRUITING

Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial

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Conditions

SchizophreniaSchizoaffective Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial

Quick Facts

Study Start:2022-03-17
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05208190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of schizophrenia or schizoaffective disorder by the Structured Clinical Interview for DSM-5 (SCID-5)
  2. * commission of a minor or serious act of violence as measured by the MCVI in the last six months
  3. * willing and able to provide informed consent
  4. * medically stable in judgment of physician providing study treatment
  5. * 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
  1. * An unstable of serious medical or neurological condition including a myeloproliferative disorder or condition that surprises the bone marrow
  2. * A history of intolerance/allergy to clozapine (e.g., agranulocytosis, small bowel obstruction, or myocarditis)
  3. * A history of intellectual impairment
  4. * pregnant or lactating women; women who are able to become pregnant but who are not willing to sue effective methods of birth control
  5. * 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
  6. * Documented intolerance to or lack of any therapeutic benefit with clozapine after a full trial

Contacts and Locations

Study Contact

Ragy Girgis
CONTACT
646-774-5553
ragy.girgis@nyspi.columbia.edu

Principal Investigator

Ragy Girgis, MD
PRINCIPAL_INVESTIGATOR
New York State Psychiatric Institute

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90024
United States
Augusta University Research Institute, Inc.
Augusta, Georgia, 30912
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201
United States
NYU Langone Medical Center
New York, New York, 10016
United States
New York State Psychiatric Institute
New York, New York, 10032
United States
Manhattan Psychiatric Center
New York, New York, 10035
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: New York State Psychiatric Institute

  • Ragy Girgis, MD, PRINCIPAL_INVESTIGATOR, New York State Psychiatric Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-17
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2022-03-17
Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia
  • Schizoaffective Disorder