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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 weeks
  • Procedures mentioned: Interviews, Blood draws, Physical exams

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "TAU on the risk for violent acts as measured by the MacArthur Community Violence Interview (MCVI) and to examine the effects of clozapine vs."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether clozapine lowers the risk of violent acts more than usual antipsychotic medicine. It is for people with schizophrenia or schizoaffective disorder who have acted violently in the past 6 months. Treatment is assigned by chance, and the study lasts 24 weeks.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have schizophrenia or schizoaffective disorder, confirmed through a study interview. These illnesses can affect thoughts, mood, and sense of reality.
  • Have committed a minor or serious violent act in the past 6 months, based on the study’s violence measure.
  • Be willing and able to understand the study and agree to take part.
  • Be medically stable, as judged by the study doctor.
  • Be a suitable candidate for either clozapine or usual antipsychotic treatment.
  • May be taking no medicine or an antipsychotic, but not clozapine or a long-acting shot given more than 30 days apart.

Who can't join

  • Have an unstable or serious medical condition or a condition affecting the brain or nerves, including certain bone marrow disorders.
  • Have had an allergy or serious reaction to clozapine, such as very low white blood cells, a blocked small intestine, or swelling of the heart muscle.
  • Have a history of an intellectual disability.
  • Be pregnant or breastfeeding, or be able to become pregnant but unwilling to use effective birth control.
  • Have a score of 3, 4, or 5 on the study’s suicide-thought rating scale in the past month.
  • Have had suicidal behavior in the past 3 months. Self-harm without an intent to die does not count for this rule.
  • Be judged by the study doctor to have too high a suicide risk to safely join a study where clozapine is not guaranteed.
  • Have records showing that a full trial of clozapine caused side effects you could not tolerate or gave no benefit.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (7)

CA

GA

MD

NC

NY