Metabolic Effects of Adjunctive Lumateperone Treatment in Clozapine-Treated Patients With Schizophrenia

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT06174116
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Lumateperone — DRUG
    Subject will take lumateperone (Caplyta) for 12 weeks, in addition to their regular medications.
  • Placebo — DRUG
    Subject will take placebo for 12 weeks, in addition to their regular medications.

Study Details

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).

Key Dates

Start date
Apr 2, 2024
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Body Mass Index (BMI) [ Time Frame: Week 0, Week 6, and Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UMass Chan Medical SchoolWorcesterMassachusetts01655
Abaigeal Grant
[email protected]
508-856-3027
Xiaoduo Fan, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Worcester, MA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
UMass Chan Medical School· Worcester, MA

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