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

Part of paid clinical trials in Los Angeles, California.

Sponsor
New York State Psychiatric Institute
Study ID
NCT05208190
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Mar 17, 2022
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Clozapine
    treatment with clozapine naturalistically administered (as per clinical guideline).
  • Active Comparator: Treatment as usual
    open label naturalistic treatment as usual with any antipsychotic other than clozapine

Primary Outcome Measure

Effectiveness outcome: Violent acts [ Time Frame: Time to violent act from randomization to treatment completion (24 weeks) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90024
Alex Kopelowicz, MD
[email protected]
818-837-8150
Augusta University Research Institute, Inc.AugustaGeorgia30912
Joseph McEvoy, MD
[email protected]
706-792-7021
University of Maryland School of MedicineBaltimoreMaryland21201
Deanna Kelly, PharmD
[email protected]
410-402-6861
Manhattan Psychiatric CenterNew YorkNew York10035
Jean-Pierre Lindenmayer, MD
[email protected]
212-249-2720
New York State Psychiatric InstituteNew YorkNew York10032
Ragy R Girgis, MD
[email protected]
646-774-5553
Ragy R Girgis, MD (PRINCIPAL_INVESTIGATOR)
Scott Stroup, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone Medical CenterNew YorkNew York10016
Donald Goff
[email protected]
646-754-4843
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Fred Jarskog, MD
[email protected]
919-842-7683

Find similar trials in Los Angeles, CA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
University of California, Los Angeles· Los Angeles, CAAugusta University Research Institute, Inc.· Augusta, GAUniversity of Maryland School of Medicine· Baltimore, MDManhattan Psychiatric Center· New York, NYNew York State Psychiatric Institute· New York, NYNYU Langone Medical Center· New York, NY

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