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Clozapine for Schizophrenia (REVISIT-C Trial)
REVISIT-C Trial Summary
This trial will study whether clozapine, a medication used to treat schizophrenia, is effective in reducing the risk of violent acts in people with schizophrenia who have a recent history of violence.
REVISIT-C Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2008 Phase 4 trial • 25 Patients • NCT00001656REVISIT-C Trial Design
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Who is running the clinical trial?
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- I do not have a serious condition affecting my blood or nervous system.I tried clozapine without success or had side effects.If you have had recent thoughts or behaviors related to suicide, or if your doctor thinks you are at a high risk for suicide, you may not be able to participate in this study.You have committed a violent act in the past six months, as determined by the MCVI assessment.I have a history of intellectual impairment.I am eligible for treatment with clozapine or standard therapy and not currently on long-term injectables.
- Group 1: Clozapine
- Group 2: Treatment as usual
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 170 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 14 Months after you stop receiving the treatment.
Frequently Asked Questions
How many hospitals are participating in this clinical trial?
"This trial is currently being conducted at 7 locations, these include the University of North carolina at Chapel Hill in Chapel Hill, New york State Psychiatric Institute in Baltimore and University of Maryland School of Medicine in Los Angeles."
Are there any constraints on who is allowed to enroll in this research project?
"The ideal candidate for this clinical trial should have a diagnosis of schizophrenia and be between 18-65 years old. So far, the team has recruited around 280 people."
Are the individuals in this study considered to be of legal age?
"This study's age requirements are that participants must have turned 18 years old but cannot be older than 65."
Could you please elaborate on the risks associated with Clozapine?
"Clozapine has been approved, meaning it is a safe and effective treatment option, so it received a score of 3."
Can new patients still sign up for this clinical trial?
"The information available on clinicaltrials.gov supports that this trial is looking for more participants. The study was first posted online on March 17th, 2022 and was most recently updated on March 25th, 2022. In total, the investigators are hoping to enroll 280 patients from 7 sites."
How many patients are being enrolled in this trial?
"That is correct, the clinicaltrials.gov website has updated information that this trial is still looking for volunteers. The study was posted on 3/17/2022 and was most recently updated on 3/25/2022. They are hoping to have 280 people participate from 7 different locations."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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