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RECRUITING
NCT06174116
PHASE4

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

Sponsor: University of Massachusetts, Worcester

View on ClinicalTrials.gov

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

Interventions

DRUG

Lumateperone

Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.

DRUG

Placebo

Subject will take placebo for 12 weeks, in addition to their regular medications.

Locations (1)

UMass Chan Medical School

Worcester, Massachusetts, United States