NCT06174116 Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
| NCT ID | NCT06174116 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Massachusetts, Worcester |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2024-04-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
Xiaoduo Fan, MD
PRINCIPAL INVESTIGATOR
UMass Chan Medical School
Frequently Asked Questions
Who can join the NCT06174116 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06174116 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06174116 currently recruiting?
Yes, NCT06174116 is actively recruiting participants. Contact the research team at abaigeal.grant2@umassmed.edu for enrollment information.
Where is the NCT06174116 trial being conducted?
This trial is being conducted at Worcester, United States.
Who is sponsoring the NCT06174116 clinical trial?
NCT06174116 is sponsored by University of Massachusetts, Worcester. The principal investigator is Xiaoduo Fan, MD at UMass Chan Medical School. The trial plans to enroll 50 participants.
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