Print

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a randomized, double-blind, placebo-controlled trial.
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo 		2 Placebo capsules taken orally per day for 12 weeks
  • Drug: Placebo
    Subject will take placebo for 12 weeks, in addition to their regular medications.
Experimental
Lumateperone 		42mg (two 21mg capsules) lumateperone (Caplyta) taken orally per day for 12 weeks
  • Drug: Lumateperone
    Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.
    Other names:
    • Caplyta

Recruiting Locations

UMass Chan Medical School
Worcester, Massachusetts 01655
Contact:
Abaigeal Grant
508-856-3027
abaigeal.grant2@umassmed.edu

More Details

Status
Recruiting
Sponsor
University of Massachusetts, Worcester

Study Contact

Abaigeal Grant, BA
5088563027
abaigeal.grant2@umassmed.edu

Detailed Description

This is a 12-week study in which we investigate how adjunctive lumateperone affects lipid particle size and body composition in clozapine-treated patients with schizophrenia; in addition, we will investigate if lumateperone improves insomnia. Outcome measures will record a variety of assessments related to participants' psychiatric symptoms, psychosocial functioning, and biological outcomes.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.