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

Description

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).

Conditions

Schizophrenia, Schizo Affective Disorder

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Worcester

UMass Chan Medical School, Worcester, Massachusetts, United States, 01655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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)

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Massachusetts, Worcester,

Xiaoduo Fan, MD, PRINCIPAL_INVESTIGATOR, UMass Chan Medical School

Study Record Dates

2026-11