Clozapine for Schizophrenia

(REVISIT-C Trial)

This trial tests clozapine, a medication, to determine its effectiveness in reducing violent behavior in people with schizophrenia. Researchers will compare clozapine to other standard antipsychotic treatments over 24 weeks. They seek participants with schizophrenia or schizoaffective disorder (a mood disorder with schizophrenia symptoms) who have experienced a violent incident in the last six months. Participants must be medically stable and able to consent to the study. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective clozapine can benefit more patients.

The trial does not specify if you need to stop taking your current medications, but you can participate if you are currently medication-free or on any antipsychotic, except clozapine or long-acting injectables with a dosing interval of more than 30 days.

Research has shown that clozapine is a highly effective treatment for schizophrenia, particularly for individuals who do not respond well to other medications. Studies indicate it outperforms other antipsychotics in reducing symptoms like hallucinations and delusions. Experts worldwide recommend clozapine for those with difficult-to-treat schizophrenia.

Clozapine has undergone thorough safety studies. While generally well-tolerated, some individuals may experience side effects such as drowsiness, increased saliva, or weight gain. It is important to note that the FDA has approved clozapine for treating schizophrenia, indicating it has passed numerous studies and is considered safe for suitable patients.

Clozapine is unique because it targets treatment-resistant schizophrenia, which means it's an option when other antipsychotics haven’t worked. Unlike most antipsychotic drugs that are used as the first line of treatment, clozapine is typically reserved for severe cases due to its effectiveness in reducing symptoms that don’t respond to standard medications like risperidone or olanzapine. Researchers are excited about clozapine because it acts on multiple neurotransmitter systems in the brain, offering a different mechanism that can be more effective for certain patients. This potential to address difficult cases of schizophrenia offers hope for better management of the condition.

Research has shown that clozapine, which participants in this trial may receive, effectively treats schizophrenia, particularly for those unresponsive to other treatments. A review of studies found that clozapine reduces schizophrenia symptoms more effectively than standard antipsychotic drugs. Other participants in this trial will receive treatment as usual, involving any antipsychotic other than clozapine. Studies also suggest that clozapine is more effective at preventing symptom recurrence, making it a strong choice for managing schizophrenia symptoms and reducing the risk of violent behavior.³⁴⁵⁶⁷