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

NCT06174116 | Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY00001339
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Schizophrenia; Schizo Affective Disorder

Keywords

Clozapine

Outcome Measures

Primary Outcomes (11)

• Body Mass Index (BMI)

  Participant Body Mass Index will be measured by standard methods

  Week 0, Week 6, and Week 12

• Waist Circumference

  Participant Waist Circumference will be measured by standard methods

  Week 0, Week 6, and Week 12

• Body Composition - Fat Mass

  Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Fat mass will be measured in grams.

  Week 0 and Week 12

• Body Composition - Total Body Mass

  Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Total Body Mass will be measured in grams.

  Week 0 and Week 12

• Body Composition - Fat Percentage

  Body Composition will be assessed using the research-grade medical body composition analyzer Seca 515/514. Fat Percentage will be calculated as fat mass (in grams) divided by total mass (in grams).

  Week 0 and Week 12

• HBA1C

  Participant HBA1C will be measured using standard labs

  Week 0 and Week 12

• Fasting Insulin

  Participant Fasting Insulin will be measured using standard labs

  Week 0, Week 6, and Week 12

• LDL Particle

  LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)

  Week 0 and Week 12

• Small LDL Particle

  Small LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)

  Week 0 and Week 12

• Large HDL Particle

  Large HDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)

  Week 0 and Week 12

• Large VLDL Particle

  Large VLDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)

  Week 0 and Week 12

Secondary Outcomes (6)

• Positive and Negative Symptoms Scale (PANSS)

  Week 0, Week 6, and Week 12

• Calgary Depression Scale (CDRS)

  Week 0, Week 6, and Week 12

• Clinical Global Impression - Severity Scale (CGI-S)

  Week 0, Week 6, and Week 12

• Clinical Global Impression - Improvement Scale (CGI-I)

  Week 0, Week 6, and Week 12

• Insomnia Severity Index (ISI)

  Week 0, Week 6, and Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

2 Placebo capsules taken orally per day for 12 weeks

Drug: Placebo

Lumateperone

EXPERIMENTAL

42mg (two 21mg capsules) lumateperone (Caplyta) taken orally per day for 12 weeks

Drug: Lumateperone

Interventions

Lumateperone DRUG

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

Also known as: Caplyta

Lumateperone

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Intra-Cellular Therapies, Inc.: collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Xiaoduo Fan, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abaigeal Grant, BA

CONTACT

5088563027; abaigeal.grant2@umassmed.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, UMass Mind

Model Details: This is a randomized, double-blind, placebo-controlled trial.

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: April 2, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)