Actively Recruiting
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Led by University of Massachusetts, Worcester · Updated on 2025-05-20
50
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
Sponsors
U
University of Massachusetts, Worcester
Lead Sponsor
I
Intra-Cellular Therapies, Inc.
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
Official Title
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meets the DSM-5 criteria for schizophrenia or schizoaffective disorder based on the 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 must use birth control during the study
You will not qualify if you...
- Psychiatrically unstable as judged by the principal investigator
- Not on a stable dose of antipsychotic medications
- Current DSM-5 substance use disorder except caffeine and nicotine
- Significant unstable medical conditions including severe cardiovascular, liver, kidney, or other diseases
- History of seizure disorder
- Pregnancy or breastfeeding
- Lumateperone treatment in the past 3 months
- Use of dopamine partial agonist antipsychotics in the past 3 months (aripiprazole, brexpiprazole, cariprazine)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655
Actively Recruiting
Research Team
A
Abaigeal Grant, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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