RecruitingPhase 4NCT06174116

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


Sponsor

University of Massachusetts, Worcester

Enrollment

50 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a medication called lumateperone (already used for schizophrenia) to clozapine treatment can reduce the serious metabolic side effects — like weight gain, high blood sugar, and abnormal cholesterol — that clozapine commonly causes in people with schizophrenia. **You may be eligible if...** - You have been diagnosed with schizophrenia or schizoaffective disorder - You have been taking clozapine for at least 6 months at a stable dose - You are psychiatrically stable and compliant with your medications - You are using appropriate birth control if you could become pregnant **You may NOT be eligible if...** - You are currently psychiatrically unstable - You have an active substance use disorder (other than caffeine or nicotine) - You have serious unstable medical conditions affecting your heart, liver, or kidneys - You have a history of seizures - You are pregnant or breastfeeding - You have taken lumateperone in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLumateperone

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

DRUGPlacebo

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


Locations(1)

UMass Chan Medical School

Worcester, Massachusetts, United States

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NCT06174116


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