NCT06174116 · University of Massachusetts, Worcester
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
What this study is about
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.
View original scientific 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).
Interventions
DRUG
Lumateperone
Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.
DRUG
Placebo
Subject will take placebo for 12 weeks, in addition to their regular medications.
Primary outcome measures
Body Mass Index (BMI)
Time frame: Week 0, Week 6, and Week 12
Participant Body Mass Index will be measured by standard methods
Waist Circumference
Time frame: Week 0, Week 6, and Week 12
Participant Waist Circumference will be measured by standard methods
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.
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.
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).
HBA1C
Time frame: Week 0 and Week 12
Participant HBA1C will be measured using standard labs
Fasting Insulin
Time frame: Week 0, Week 6, and Week 12
Participant Fasting Insulin will be measured using standard labs
LDL Particle
Time frame: Week 0 and Week 12
LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Small LDL Particle
Time frame: Week 0 and Week 12
Small LDL particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Large HDL Particle
Time frame: Week 0 and Week 12
Large HDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Large VLDL Particle
Time frame: Week 0 and Week 12
Large VLDL Particle size will be determined using the NMR spectroscopy (LipoScience, Raleigh, NC)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Worcester, Massachusetts
Collaborators
Intra-Cellular Therapies, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations