Study of Clozapine and Risperidone Treatment in Adults with Schizophrenia, Schizoaffective Disorder, or Bipolar I Disorder

What this Trial Is About

Researchers are evaluating the effects of clozapine in individuals with psychosis, including schizophrenia, schizoaffective disorder, and bipolar I disorder with psychotic features. The study aims to understand how people classified as Biotype 1 B1, characterized by low intrinsic EEG activity, respond uniquely to clozapine compared to those in Biotype 2 B2. This research uses a randomized, double-blinded, parallel group design to assess these responses more precisely. Participants will be assigned to one of four groups receiving either clozapine or risperidone, with doses up to 500 mg daily for clozapine and up to 6 mg daily for risperidone. Additional medications for symptom management, such as melatonin, hydroxyzine, benztropine, and propranolol, are allowed at standard clinical doses. The study will enroll about 320 participants, divided between B1 and B2 groups, to compare the biomedical effects of these treatments. During participation, individuals will be monitored at specific weeks to assess changes in symptom severity using the PANSS total score at weeks 4, 10, and 18. Researchers will conduct clinical evaluations, laboratory tests including neutrophil counts, and track medication adherence and side effects. The study is expected to continue until April 2027, with careful monitoring of treatment response and safety throughout.

CLOZAPINE Response in Biotype-1