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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia, Schizo Affective Disorder

In brief

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 facts

Study ID

NCT06174116

Run by

University of Massachusetts, Worcester

People needed

50

Starts

2024-04-02

Expected to finish

2027-03-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the MINI International Neuropsychiatric Interview (MINI 7.0)
• On clozapine treatment for at least 6 months
• Stable dose of antipsychotic treatment for at least 1 month
• Well established compliance with outpatient medications
• Subjects of child-bearing potential are required to practice appropriate birth control methods during the study.

You may not qualify if…

• Psychiatrically unstable per clinical judgement by the principal investigator
• Patients not on stable dose of antipsychotic medications
• Currently meets DSM-5 criteria for any substance use disorder other than caffeine and nicotine
• Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases
• History of a seizure disorder
• Pregnancy or breastfeeding
• On lumateperone treatment in the past 3 months
• On a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)

Where it is running

• UMass Chan Medical School — Worcester, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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