RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-04-02
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06174116

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder based on the MINI International Neuropsychiatric Interview (MINI 7.0)
  2. * On clozapine treatment for at least 6 months
  3. * Stable dose of antipsychotic treatment for at least 1 month
  4. * Well established compliance with outpatient medications
  5. * Subjects of child-bearing potential are required to practice appropriate birth control methods during the study.
  1. * Psychiatrically unstable per clinical judgement by the principal investigator
  2. * Patients not on stable dose of antipsychotic medications
  3. * Currently meets DSM-5 criteria for any substance use disorder other than caffeine and nicotine
  4. * Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases
  5. * History of a seizure disorder
  6. * Pregnancy or breastfeeding
  7. * On lumateperone treatment in the past 3 months
  8. * On a dopamine partial agonist antipsychotic agent in the past 3 months (aripiprazole, brexpiprazole, cariprazine)

Contacts and Locations

Study Contact

Abaigeal Grant, BA
CONTACT
5088563027
abaigeal.grant2@umassmed.edu

Principal Investigator

Xiaoduo Fan, MD
PRINCIPAL_INVESTIGATOR
UMass Chan Medical School

Study Locations (Sites)

UMass Chan Medical School
Worcester, Massachusetts, 01655
United States

Collaborators and Investigators

Sponsor: University of Massachusetts, Worcester

  • Xiaoduo Fan, MD, PRINCIPAL_INVESTIGATOR, UMass Chan Medical School

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-02
Study Completion Date2026-11

Study Record Updates

Study Start Date2024-04-02
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • Clozapine

Additional Relevant MeSH Terms

  • Schizophrenia
  • Schizo Affective Disorder