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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity & Overweight; Bipolar Depression Depressed Phase
• Intervention / Treatment: Drug: Lumateperone 42 mg

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Natalie Herbold, BS; Phone Number: 6177248986; Email: nherbold@mgh.harvard.edu
• Study Contact Backup: Name: Michael E Henry, MD; Phone Number: 6176435759; Email: mhenry14@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
      • Contact: Michael E Henry, MD; Phone Number: 6176435750; Email: mhenry14@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18 to 65 years.
2. Meets DSM-V criteria for Bipolar I Disorder -Depressed without psychosis as confirmed by a semi-structured clinical interview that includes the Mini International Neuropsychiatric Interview.
3. Current episode at least 4 weeks in duration but not longer than 12 months.
4. Depression score > 20 on the Montgomery Asberg Depression Rating Scale (MADRS).
5. BMI > 30
6. Capable of providing informed consent.

Exclusion Criteria:

1. Meets DSM-V criteria for Schizophrenia, Schizoaffective disorder, or has significant mood-incongruent psychotic symptoms.
2. Young Mania Rating Scale score >12.
3. Meets DSM-V criteria for rapid cycling.
4. Co-Morbid psychiatric illness, other than generalized anxiety and specific phobias, that in the opinion of the investigator is severe enough that it would likely interfere with the interpretation of changes in the subject's mood state.
5. Meets DSM-V criteria for an active substance use disorder within the past month.
6. Active medical condition that in the opinion of the investigator would contribute to the subject's depressed mood (e.g. hypothyroidism).
7. Significant risk of suicide or self -harm as assessed by clinical interview and the Columbia Suicide Severity Rating Scale (C-SSRS).
8. Significant risk of harm to others as assessed by clinical interview.
9. Pregnancy, or, in women of child-bearing potential, an unwillingness to use an accepted method of birth control for the duration of the study.
10. Current or prior treatment with lumateperone.
11. Moderate or severe hepatic impairment.
12. Current treatment with strong or moderate CYP3A4 inhibitors or CYP3A4 inducers.
13. History of seizure disorder.
14. Significant cardiovascular or cerebrovascular disease that, in the opinion of the investigator, would increase study risk.
15. Dementia-related psychosis.
16. Known hypersensitivity or allergy to lumateperone or any of its components.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumateperone treatment; Lumateperone treatment for Bipolar type I depression	Drug: Lumateperone 42 mg; Lumateperone 42 mg orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MADRS	Montgomery Asperg Depression Rating Scale	6 week
Inflammatory Markers	Tissue Necrosis factor alpha, C-reactive protein, Interleukins 1 beta, 6, 18	6 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Johnson and Johnson Medical
• Investigators: Principal Investigator: Michael E Henry, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Depression; obesity; Bipolar disorder
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Behavioral Symptoms; Mood Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Depression; Bipolar Disorder; lumateperone
• Other Study ID Numbers: 2026P001267

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No