Clinical Trial

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

Recruiting Phase 4
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Summary
The main question this study is trying to answer is whether lumateperone, an FDA-approved antipsychotic drug, can help reduce possible side effects of clozapine, such as weight gain and elevated levels of sugar and bad cholesterol. Participants will be randomly assigned to either take lumateperone (Caplyta) or a placebo for 12 weeks, in addition to their regularly prescribed clozapine. During their participation, patients will answer questions about their psychiatric and daily functioning, have blood drawn, and have their body composition analyzed (similar to stepping on a scale).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-12-08; most recent amendment 2026-05-20.
Status change: Not Yet Recruiting → Recruiting 2024-03-19
Status change: Recruiting → Not Yet Recruiting 2024-01-08
Trial Details
NCT Number NCT06174116
Lead Sponsor University of Massachusetts, Worcester
Collaborators: Intra-Cellular Therapies, Inc.
Conditions Schizophrenia, Schizo Affective Disorder
Enrollment 50 participants
Start Date 2024-04-02
Primary Completion 2026-12 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-05-22