Lumateperone for Bipolar Depression with Obesity: Effects on Mood and Brain Aging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18-65 with bipolar I depression and obesity will receive lumateperone 42 mg for roughly six weeks. The study will measure mood symptoms, inflammation, and a brain-age biomarker from MRI at baseline to explore potential links between physical health, brain aging, and antidepressant response. It is conducted at Massachusetts General Hospital with collaboration from Johnson & Johnson K.K. Medical Company. The primary goal is to see if the medication can improve depressive symptoms and relate these changes to biological and imaging markers. MRI-based brain aging will be assessed at the start of the study to establish a baseline biomarker profile.

Why it matters

Who can join: the full rules

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.

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Michael E Henry, MD — Massachusetts General Hospital
• Study coordinator: Natalie Herbold, BS
• Email: nherbold@mgh.harvard.edu
• Phone: 6177248986

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.