Lumateperone for Depression in Bipolar Disorder, With Weight and Brain Aging Measured
Tests lumateperone for mood symptoms in adults with bipolar depression and overweight.
Plain-language title generated from the registry record
Registry title: The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression
Key facts
- Where
- Boston, United StatesSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07699445, who can take part
Where in United States
- Massachusetts General HospitalBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT07699445
- Record updated
- 11 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Current or prior treatment with lumateperone; Current treatment with strong or moderate CYP3A4 inhibitors or CYP3A4 inducers; Meets DSM-V criteria for Schizophrenia, Schizoaffective disorder, or has significant mood-incongruent psychotic symptoms; 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); Moderate or severe hepatic impairment; History of seizure disorder; Significant cardiovascular or cerebrovascular disease that, in the opinion of the investigator, would increase study risk; Dementia-related psychosis; Known hypersensitivity or allergy to lumateperone or any of its components; Young Mania Rating Scale score >12; Meets DSM-V criteria for rapid cycling; 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.