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Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Sponsor: University of Massachusetts, Worcester
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).
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-04-02
Completion Date
2026-11
Last Updated
2025-05-20
Healthy Volunteers
No
Conditions
Interventions
Lumateperone
Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.
Placebo
Subject will take placebo for 12 weeks, in addition to their regular medications.
Locations (1)
UMass Chan Medical School
Worcester, Massachusetts, United States