Recruiting

Lumateperone with Clozapine

Sponsor:

University of Massachusetts, Worcester

Code:

NCT06174116

Conditions

Schizophrenia

Schizo Affective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Lumateperone

Placebo

Study Details

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).

Conditions

Schizophrenia

Schizo Affective Disorder

Study ID

NCT06174116

Start date

Apr 2, 2024

Status verified date

May, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

2 Placebo capsules taken orally per day for 12 weeks

experimental: Lumateperone

42mg (two 21mg capsules) lumateperone (Caplyta) taken orally per day for 12 weeks

Interventions

Lumateperone

Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.

Placebo

Subject will take placebo for 12 weeks, in addition to their regular medications.

Primary outcome measure

  • Body Mass Index (BMI) [ Time Frame: Week 0, Week 6, and Week 12 ]
  • Waist Circumference [ Time Frame: Week 0, Week 6, and Week 12 ]
  • Body Composition - Fat Mass [ Time Frame: Week 0 and Week 12 ]
  • Body Composition - Total Body Mass [ Time Frame: Week 0 and Week 12 ]
  • Body Composition - Fat Percentage [ Time Frame: Week 0 and Week 12 ]
  • HBA1C [ Time Frame: Week 0 and Week 12 ]
  • Fasting Insulin [ Time Frame: Week 0, Week 6, and Week 12 ]
  • LDL Particle [ Time Frame: Week 0 and Week 12 ]
  • Small LDL Particle [ Time Frame: Week 0 and Week 12 ]
  • Large HDL Particle [ Time Frame: Week 0 and Week 12 ]
  • Large VLDL Particle [ Time Frame: Week 0 and Week 12 ]

Central Contacts and Locations

Central contacts

Abaigeal Grant, BA

5088563027abaigeal.grant2@umassmed.edu

Locations

UMass Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Abaigeal Grant

508-856-3027abaigeal.grant2@umassmed.edu

Principal Investigator:

Xiaoduo Fan, MD, MPH

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Clozapine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-05-22.