The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07699445
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Bipolar Depression Depressed Phase
  • Obesity & Overweight

Eligibility Criteria

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

Interventions

  • Lumateperone 42 mg — DRUG
    Lumateperone 42 mg orally daily

Study Details

This research study examines how a medication called lumateperone may affect mood symptoms, and inflammation in adults with bipolar disorder over approximately 6 weeks. An MRI scan to calculate biological age of the brain will also be obtained at the start of the study.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lumateperone treatment
    Lumateperone treatment for Bipolar type I depression

Primary Outcome Measure

MADRS [ Time Frame: 6 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Michael E Henry, MD
[email protected]
6176435750

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By research site
Massachusetts General Hospital· Boston, MA

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