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Prevention study for Schizophrenia
Official title Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial
ClinicalTrials.gov ID: NCT05208190
What this study is testing
What is Clozapine?
Clozapine is an investigational medicine, being studied as a potential treatment for schizophrenia.
Also referred to as clozaril.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of schizophrenia or schizoaffective disorder by the Structured Clinical Interview for DSM-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...
You likely can't join if
- 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)...
- Documented intolerance to or lack of any therapeutic benefit with clozapine after a full trial
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Augusta, Georgia, United States
- Baltimore, Maryland, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Augusta, Georgia, United States; Baltimore, Maryland, United States; New York, New York, United States; Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.