Effects of lumateperone on metabolic side effects in patients taking clozapine for schizophrenia
Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia
PHASE4 · University of Massachusetts, Worcester · NCT06174116
This study is testing if adding lumateperone to clozapine treatment can help people with schizophrenia reduce weight gain and cholesterol issues caused by their medication.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester (other) |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT06174116 on ClinicalTrials.gov |
What this trial studies
This study investigates whether lumateperone, an FDA-approved antipsychotic, can mitigate metabolic side effects such as weight gain and elevated cholesterol in patients treated with clozapine for schizophrenia. Participants will be randomly assigned to receive either lumateperone or a placebo for 12 weeks, alongside their ongoing clozapine treatment. The study will assess various outcomes, including psychiatric symptoms, psychosocial functioning, and biological measures related to body composition and lipid levels. Participants will also report on their sleep quality during the trial.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with schizophrenia or schizoaffective disorder who have been on a stable dose of clozapine for at least six months.
Not a fit: Patients with unstable psychiatric conditions or significant medical issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help reduce metabolic side effects in patients with schizophrenia who are treated with clozapine.
How similar studies have performed: Other studies have shown promise in using adjunctive treatments to manage side effects of antipsychotics, but this specific approach with lumateperone is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Worcester, Massachusetts
- UMass Chan Medical School — Worcester, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Xiaoduo Fan, MD — UMass Chan Medical School
- Study coordinator: Abaigeal Grant, BA
- Email: abaigeal.grant2@umassmed.edu
- Phone: 5088563027
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia, Schizo Affective Disorder, Clozapine