Status:
RECRUITING
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
Intra-Cellular Therapies, Inc.
Conditions:
Schizophrenia
Schizo Affective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 level...
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 inve...
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)
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06174116
Start Date
April 2 2024
End Date
November 1 2026
Last Update
May 20 2025
Active Locations (1)
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1
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655