NCT06174116RecruitingPhase 4
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 8 Dec 2023
- Start date
- Apr 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Massachusetts, Worcester
- Diseases
- Schizophrenia
- NCT number
- NCT06174116
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From Apr 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients not on stable dose of antipsychotic medications
Other illness
- 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
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMass Chan Medical School Coordinator of this site? Confirm its status | Worcester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.