Evaluating Lumateperones Effects on Metabolism and Sleep in Adults Taking Clozapine for Schizophrenia or Schizoaffective Disorder

What this Trial Is About

Researchers are investigating whether lumateperone Caplyta, an FDA-approved antipsychotic drug, can help reduce side effects like weight gain, high blood sugar, and elevated bad cholesterol in patients with schizophrenia or schizoaffective disorder who are already being treated with clozapine. This phase 4 study also explores if lumateperone improves insomnia and assesses various psychiatric symptoms and psychosocial functioning. Participants will be randomly assigned to take either lumateperone 42 mg daily as two 21 mg capsules or a placebo for 12 weeks, alongside their usual clozapine treatment. During this period, they will take the assigned capsules orally every day and be monitored for changes in lipid particle size, body composition, and insomnia symptoms. Throughout the study, participants will complete questionnaires about their psychiatric health and daily functioning. Their body composition will be measured, and blood samples will be collected to assess factors such as body mass index, waist circumference, fat mass, blood sugar control HBA1C, insulin levels, and cholesterol particles at various points including weeks 0, 6, and 12. Safety and symptom assessments will also be conducted regularly during the 12 weeks of treatment.

Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia