NCT07699445

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
24mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

July 31, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Bipolar Depression Depressed PhaseObesity & Overweight

Keywords

Bipolar disorderDepressionobesity

Outcome Measures

Primary Outcomes (2)

  • MADRS

    Montgomery Asperg Depression Rating Scale

    6 week

  • Inflammatory Markers

    Tissue Necrosis factor alpha, C-reactive protein, Interleukins 1 beta, 6, 18

    6 weeks

Study Arms (1)

Lumateperone treatment

EXPERIMENTAL

Lumateperone treatment for Bipolar type I depression

Drug: Lumateperone 42 mg

Interventions

Lumateperone 42 mgDRUG

Lumateperone 42 mg orally daily

Lumateperone treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 65 years.
  • 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.
  • Current episode at least 4 weeks in duration but not longer than 12 months.
  • Depression score \> 20 on the Montgomery Asberg Depression Rating Scale (MADRS).
  • BMI \> 30
  • Capable of providing informed consent.

You may not qualify if:

  • Meets DSM-V criteria for Schizophrenia, Schizoaffective disorder, or has significant mood-incongruent psychotic symptoms.
  • Young Mania Rating Scale score \>12.
  • Meets DSM-V criteria for rapid cycling.
  • 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.
  • Meets DSM-V criteria for an active substance use disorder within the past month.
  • Active medical condition that in the opinion of the investigator would contribute to the subject's depressed mood (e.g. hypothyroidism).
  • Significant risk of suicide or self -harm as assessed by clinical interview and the Columbia Suicide Severity Rating Scale (C-SSRS).
  • Significant risk of harm to others as assessed by clinical interview.
  • Pregnancy, or, in women of child-bearing potential, an unwillingness to use an accepted method of birth control for the duration of the study.
  • Current or prior treatment with lumateperone.
  • Moderate or severe hepatic impairment.
  • Current treatment with strong or moderate CYP3A4 inhibitors or CYP3A4 inducers.
  • History of seizure disorder.
  • Significant cardiovascular or cerebrovascular disease that, in the opinion of the investigator, would increase study risk.
  • Dementia-related psychosis.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

ObesityOverweightBipolar DisorderDepression

Interventions

lumateperone

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Michael E Henry, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Herbold, BS

CONTACT

6177248986nherbold@mgh.harvard.edu

Michael E Henry, MD

CONTACT

6176435759mhenry14@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Subjects with bipolar disorder type I depressed phase with comorbid obesity will receive open label lumateperone. Baseline weight, serum markers of inflammation, and a structural MRI scan will be obtained pretreatment. Weight and serum markers of inflammation will be measured post treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

July 31, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

July 13, 2026

Record last verified: 2026-07

Locations

US(1)