Effects of lumateperone on metabolic side effects in patients taking clozapine for schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Clubhouse-based care for people with schizophrenia and related conditions

  This study tests whether the Clubhouse Model of psychosocial rehabilitation helps thinking skills and daily function more than usual community mental health care in adults with schizophrenia, schizoaffective disorder, or schizophreniform disorders.

  Recruiting Case Western Reserve University · Cleveland, Ohio · NCT07006935

• Using Lumateperone to improve motivation in patients with schizophrenia and psychosis

  This study is testing if Lumateperone can help people with schizophrenia or schizoaffective disorders feel more motivated and less apathetic.

  Recruiting Phase 3 Louisiana State University Health Sciences Center Shreveport · Shreveport, Louisiana · NCT06482554

• Sodium benzoate added to standard treatment for treatment-resistant schizophrenia

  This study tests whether adding sodium benzoate helps people with treatment-resistant schizophrenia see better symptoms and cognition.

  Recruiting Phase 2 National Cheng-Kung University Hospital · Chiayi City · NCT06340789

• Using iTBS to Improve Social Cognition in People with Psychosis

  This study is testing whether a new brain stimulation treatment can help people with schizophrenia improve their social skills and thinking.

  Recruiting Northwell Health · Glen Oaks, New York · NCT06118268

• Virtual reality program to improve cognitive skills in people with psychosis

  This study tests whether a virtual reality program can help people with psychosis improve their thinking and social skills over six weeks.

  Recruiting The Royal Ottawa Mental Health Centre · Ottawa, Ontario · NCT05973110

• Examining the effects of combined therapy for schizophrenia

  This study is testing whether combining two therapies, one for managing thoughts and another for improving cognitive skills, can help people with schizophrenia do better in their daily lives compared to using just one of the therapies.

  Recruiting at 2 sites University of Toronto · Scarborough Village, Ontario and 1 other locations · NCT05731414

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.