Lumateperone for Bipolar Depression and Obesity

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

Recruiting Phase 4 Interventional Study
Bipolar Depression Depressed Phase Obesity & Overweight
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for

This trial is looking for adults aged 18 to 65 with bipolar depression and obesity. Participants will take a medication called lumateperone for about 6 weeks and undergo a brain scan at the start of the study.

Are You a Good Fit for This Trial?
Rules you out Seizure disorderDementia-related psychosisHepatic impairmentSevere cardiovascular disease

You may be able to join if

  • I am between 18 and 65 years old.
  • I have been diagnosed with Bipolar I Disorder - Depressed phase.
  • My current depressive episode has lasted at least 4 weeks.
  • I have a depression score above 20.
  • My BMI is over 30.
  • I am capable of providing informed consent.

You may not be able to join if

  • I have schizophrenia or significant mood-incongruent psychotic symptoms.
  • I have a Young Mania Rating Scale score above 12.
  • I have rapid cycling in my bipolar disorder.
  • I have a severe psychiatric illness that affects my mood.
  • I have had a substance use disorder in the last month.
  • I have an active medical condition affecting my mood.
  • I am at significant risk of suicide or self-harm.
  • I am currently pregnant or unwilling to use birth control.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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 Locations
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Eligibility Criteria
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 longe…
Contacts

Natalie Herbold, BS

6177248986

nherbold@mgh.harvard.edu

CONTACT

Michael E Henry, MD

6176435759

mhenry14@mgh.harvard.edu

CONTACT