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

Last updated: May 15, 2025
Sponsor: University of Massachusetts, Worcester
Overall Status: Active - Recruiting

Phase

4

Condition

Tourette's Syndrome

Mood Disorders

Schizophrenia And Schizoaffective Disorders (Pediatric)

Treatment

Lumateperone

Placebo

Clinical Study ID

NCT06174116
STUDY00001339
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorderbased 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 birthcontrol methods during the study.

Exclusion

Exclusion Criteria:

  • 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 caffeineand 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)

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Lumateperone
Phase: 4
Study Start date:
April 02, 2024
Estimated Completion Date:
November 30, 2026

Study Description

This is a 12-week study in which we investigate how adjunctive lumateperone affects lipid particle size and body composition in clozapine-treated patients with schizophrenia; in addition, we will investigate if lumateperone improves insomnia. Outcome measures will record a variety of assessments related to participants' psychiatric symptoms, psychosocial functioning, and biological outcomes.

Connect with a study center

  • UMass Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

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