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

March 19, 2024 updated by: Xiaoduo Fan, University of Massachusetts, Worcester

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Chan Medical School
        • Contact:
        • Principal Investigator:
          • Xiaoduo Fan, MD, MPH

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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.

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 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Subject will take placebo for 12 weeks, in addition to their regular medications.
Experimental: Lumateperone
Drug: Lumateperone
Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.
Other Names:
  • Caplyta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: Week 0, Week 6, and Week 12
Participant Body Mass Index will be measured by standard methods
Week 0, Week 6, and Week 12
Waist Circumference
Time Frame: Week 0, Week 6, and Week 12
Participant Waist Circumference will be measured by standard methods
Week 0, Week 6, and Week 12
Body Composition - Fat Mass
Time Frame: Week 0 and Week 12
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
Time Frame: Week 0 and Week 12
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
Time Frame: Week 0 and Week 12
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
Time Frame: Week 0 and Week 12
Participant HBA1C will be measured using standard labs
Week 0 and Week 12
Fasting Insulin
Time Frame: Week 0, Week 6, and Week 12
Participant Fasting Insulin will be measured using standard labs
Week 0, Week 6, and Week 12
LDL Particle
Time Frame: Week 0 and Week 12
LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Week 0 and Week 12
Small LDL Particle
Time Frame: Week 0 and Week 12
Small LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Week 0 and Week 12
Large HDL Particle
Time Frame: Week 0 and Week 12
Large HDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Week 0 and Week 12
Large VLDL Particle
Time Frame: Week 0 and Week 12
Large VLDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Week 0 and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Symptoms Scale (PANSS)
Time Frame: Week 0, Week 6, and Week 12
PANSS is a measure used to assess symptom severity in patients with schizophrenia. It consists of three sections: Positive scale has 7 items, Negative scale has 7 items, and General Psychopathology has 16 items. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme.
Week 0, Week 6, and Week 12
Calgary Depression Scale (CDRS)
Time Frame: Week 0, Week 6, and Week 12
The CDRS is used to assess depression symptoms in patients with schizophrenia.
Week 0, Week 6, and Week 12
Clinical Global Impression - Severity Scale (CGI-S)
Time Frame: Week 0, Week 6, and Week 12
The CGI-S is an observer rated scale. The CGI-S measures illness severity on a 7-point Likert scale 1) Normal, not at all ill, 2) Borderline mentally ill, 3) Mildly ill, 4) Moderately ill, 5) Markedly ill, 6) Severely ill, and 7) Among the most extremely ill patient.
Week 0, Week 6, and Week 12
Clinical Global Impression - Improvement Scale (CGI-I)
Time Frame: Week 0, Week 6, and Week 12
The CGI-I is an observer rated scale. The CGI-I is used to measure improvement in illness and uses a 7-point Likert scale: 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change 5) Minimally worse, 6) Much worse, 7) Very much worse.
Week 0, Week 6, and Week 12
Insomnia Severity Index (ISI)
Time Frame: Week 0, Week 6, and Week 12
The ISI is a 7-question survey assessing symptoms of insomnia. The maximum score is 28 with higher scores indicating greater severity. The ISI is a reliable and valid instrument to assess insomnia and treatment response.
Week 0, Week 6, and Week 12
Henrichs Carpenter Quality of Life Scale (QLS)
Time Frame: Week 0, Week 6, and Week 12
The QLS is a 21-item scale providing information on symptoms and functioning in patients with schizophrenia.
Week 0, Week 6, and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

Intra-Cellular Therapies, Inc.

Investigators

  • Principal Investigator: Xiaoduo Fan, MD, 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 Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00001339

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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