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RecruitingBipolar Depression Depressed PhaseObesity & Overweight

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

Eligible age

18–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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.

Sponsor: Massachusetts General Hospital

You may qualify if…

  • ✓ 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.

You may not qualify if…

  • ✕ 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.

Where it's recruiting

Massachusetts

Boston

Source: ClinicalTrials.gov · NCT07699445 · last updated 2026-09-11