Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
NCT06174116
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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 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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Schizophrenia
- Schizo Affective Disorder
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 4
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- University of Massachusetts, Worcester
- Last updated on ClinicalTrials.gov
- May 22, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Massachusetts · 1
- UMass Chan Medical School · Worcester, MA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.