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Clinical trial

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

ID
Name
STUDY00001339
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).
Trial arms
Trial start
2024-04-02
Estimated PCD
2026-08-01
Trial end
2026-11-01
Status
Recruiting
Phase
Early phase I
Treatment
Lumateperone
Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.
Arms:
Lumateperone
Other names:
Caplyta
Placebo
Subject will take placebo for 12 weeks, in addition to their regular medications.
Arms:
Placebo
Size
50
Primary endpoint
Body Mass Index (BMI)
Week 0, Week 6, and Week 12
Waist Circumference
Week 0, Week 6, and Week 12
Body Composition - Fat Mass
Week 0 and Week 12
Body Composition - Total Body Mass
Week 0 and Week 12
Body Composition - Fat Percentage
Week 0 and Week 12
HBA1C
Week 0 and Week 12
Fasting Insulin
Week 0, Week 6, and Week 12
LDL Particle
Week 0 and Week 12
Small LDL Particle
Week 0 and Week 12
Large HDL Particle
Week 0 and Week 12
Large VLDL Particle
Week 0 and Week 12
Eligibility criteria
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, double-blind, placebo-controlled trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-05-03

1 organization

1 product

1 drug

2 indications

Organization
University of Massachusetts, Worcester
Product
Lumateperone
Indication
Schizophrenia
Indication
Schizoaffective disorder
Drug
Varlilumab