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Clozapine vs Risperidone for Psychosis
Study Summary
This trial is designed to study the effects of the medication clozapine on people with psychosis, including schizophrenia, schizoaffective disorder, and psychotic bipolar I disorder. The trial will compare the effects of clozapine to a control group taking risperidone. The study sample will be comprised of n=524 individuals with psychosis, who will be randomly assigned to either the clozapine group or the control group. The investigators plan to follow the participants for a biomedical outcome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have had a severe allergic reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or Drug-Induced Hypersensitivity Syndrome (DIHS) in the past.I do not have severe neurological or medical conditions affecting my brain.I am between 18 and 60 years old.You are currently having thoughts about hurting someone and have a detailed plan on how to do it, which means you cannot receive treatment as an outpatient.My health condition is currently stable.You are not willing to use a reliable method of birth control.I have had neuroleptic malignant syndrome in the past.You have a high score on a test that measures symptoms of mental illness, specifically the PANSS test.I've had severe side effects or no improvement with clozapine or risperidone.You have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar I disorder with psychotic features according to specific guidelines.I am not taking medications that significantly affect brain wave tests or cannot be stopped safely.I have not taken clozapine or long-acting injectable antipsychotics recently.You have been diagnosed with alcohol or drug abuse in the past month, or drug dependence in the past three months.
- Group 1: Biotype 2 - Risperidone (B2R)
- Group 2: Biotype 2 - Clozapine (B2C)
- Group 3: Biotype 1 - Clozapine (B1C)
- Group 4: Biotype 1 - Risperidone (B1R)
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the Food and Drug Administration recognize clozapine as an accepted treatment?
"The safety of clozapine is confidently rated at 3 on our 1-3 scale, as this treatment has been approved by the FDA and is currently in Phase 4 trials."
What are the qualifications for participating in this experiment?
"To qualify for this trial, applicants must have schizophrenia and an age between 18-55 years. The research team is recruiting approximately 524 people to participate in the study."
Are there any available openings in this clinical research study?
"Affirmative. Per the information on clinicaltrials.gov, recruitment for this trial is ongoing. It was posted to the database on January 24th 2022 and updated most recently February 22nd 2022; 524 individuals are needed at a single location."
What is the current capacity of participants for this investigation?
"Affirmative. According to clinicaltrials.gov, this medical trial has begun recruitment and requires 524 participants at a single site. The information was initially posted on January 24th 2022 before being updated on February 22nd of the same year."
What is the primary purpose of clozapine treatment?
"Clozapine has proven to be a successful intervention for acute coryza, treatment-resistant schizophrenia, and situations where other therapies have failed."
Does this clinical trial invite participants aged 80 or older?
"This experiment is open to participants aged 18-55 years old."
Has clozapine been the subject of any prior investigations?
"Presently, 17 trials centred around clozapine are underway with 1 of them in its third phase. Toronto is the primary site for these studies; however, there are 139 locations across North America that have registered clinical trials involving this medication."
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