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Lumateperone for Metabolic Side Effects in Clozapine-Treated Schizophrenia

This study is looking into whether adding lumateperone (Caplyta) to your current clozapine medication can help reduce common side effects like weight gain and changes in blood sugar or cholesterol levels. You could be eligible if you are 18-65 years old, have schizophrenia or schizoaffective disorder, and have been taking clozapine for at least six months. Participants will be randomly assigned to take either lumateperone or a placebo (an inactive pill) for 12 weeks, in addition to their regular clozapine. Researchers will measure your Body Mass Index (BMI), waist size, and body fat to see if lumateperone helps. The study aims to enroll 50 participants, but its current status is unclear.

Study design
This is an interventional study with 50 planned participants. You will be randomly assigned to receive either lumateperone or a placebo in addition to your regular medication.
What's involved
You will take either lumateperone or a placebo for 12 weeks. During this time, you will answer questions, have blood drawn, and have your body composition analyzed.
Compensation
Not stated in the trial record.
Follow-up
Your BMI and waist circumference will be measured at Week 0, Week 6, and Week 12. Body composition will be measured at Week 0 and Week 12.

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NCT06174116

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

Recruiting
PHASE4Ages 18–65InterventionalTreatment
University of Massachusetts, Worcester
~50 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:LumateperonePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Body Mass Index (BMI)
Measured over Week 0, Week 6, and Week 12
+10 more outcomes measured

Conditions

Schizophrenia
Schizo Affective Disorder

Explore related trials

Schizoaffective DisorderSchizophrenia

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

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

Who to contact

Abaigeal Grant, BA
[email protected]
5088563027
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Body Mass Index (BMI)Week 0, Week 6, and Week 12

    Participant Body Mass Index will be measured by standard methods

  • Waist CircumferenceWeek 0, Week 6, and Week 12

    Participant Waist Circumference will be measured by standard methods

  • Body Composition - Fat MassWeek 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.

  • Body Composition - Total Body MassWeek 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.

  • Body Composition - Fat PercentageWeek 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).

  • HBA1CWeek 0 and Week 12

    Participant HBA1C will be measured using standard labs

  • Fasting InsulinWeek 0, Week 6, and Week 12

    Participant Fasting Insulin will be measured using standard labs

  • LDL ParticleWeek 0 and Week 12

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

  • Small LDL ParticleWeek 0 and Week 12

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

  • Large HDL ParticleWeek 0 and Week 12

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

  • Large VLDL ParticleWeek 0 and Week 12

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