Clozapine vs Risperidone for Psychosis
What You Need to Know Before You Apply
What is the purpose of this trial?
The CLOZAPINE study is designed as a multisite study across 5 sites and is a clinical trial, involving human participants who are prospectively assigned to an intervention. The study will utilize a stringent randomized, double-blinded, parallel group clinical trial design. B2 group will serve as psychosis control with risperidone as medication control. The study is designed to evaluate effect of clozapine on the B1 participants, and the effect that will be evaluated is a biomedical outcome. The study sample will be comprised of individuals with psychosis, including 1) schizophrenia, 2) schizoaffective disorder and 3) psychotic bipolar I disorder. The investigators plan to initially screen and recruit n=524 (from both the existing B-SNIP library and newly-identified psychosis cases, \~50% each) in order to enroll n=320 (B1 and B2) into the RCT.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that affect EEG properties or interact with the study drugs, such as lithium, anticonvulsants, benzodiazepines, and some antibiotics and seizure medications. If you are on these, you may need to discontinue them safely before participating.
What safety data exists for Clozapine and Risperidone?
How does the drug clozapine differ from other treatments for psychosis?
Clozapine is unique because it is specifically effective for treatment-resistant schizophrenia, meaning it works for patients who do not respond to other antipsychotic drugs. Unlike many other antipsychotics, clozapine has a low D2-blocking effect, which can make it necessary to combine it with other medications to fully manage symptoms.46789
What data supports the effectiveness of the drugs clozapine and risperidone for treating psychosis?
Clozapine has been shown to be effective in up to 60% of patients with treatment-resistant schizophrenia, and it provides significant symptom improvement over other second-generation antipsychotic drugs. Risperidone may be equally effective as clozapine in some cases, but more research is needed to confirm this.69101112
Who Is on the Research Team?
Carol A Tamminga, MD
Principal Investigator
UT Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with schizophrenia, schizoaffective disorder, or bipolar I with psychotic features. Participants must be medically stable, have a certain level of symptom severity, and not belong to vulnerable groups like pregnant women. They shouldn't have used clozapine before or certain long-acting antipsychotics recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive clozapine or risperidone treatment, with concomitant medications for symptomatic management
Stable Treatment
Participants continue on a stable dose of clozapine or risperidone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Clozapine
- Risperidone
Clozapine is already approved in United States, European Union for the following indications:
- Schizophrenia
- Borderline Personality Disorder
- Paranoid Disorder
- Schizophrenia
- Treatment-resistant schizophrenia
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
University of Georgia
Collaborator
Hartford Hospital
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
University of Chicago
Collaborator