Testing lumateperone added to clozapine for schizophrenia-related metabolic side effects
Tests lumateperone added to clozapine in adults with schizophrenia to ease metabolic side effects.
Plain-language title generated from the registry record
Registry title: Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Key facts
- Where
- Worcester, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06174116, who can take part
Where in United States
- UMass Chan Medical SchoolWorcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Massachusetts, Worcester
- Trial code
- NCT06174116
- Record updated
- 22 May 2026
- Original 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.Read full original descriptionShow less
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
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).
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: 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; Psychiatrically unstable per clinical judgement by the principal investigator; 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).