NCT07699445RecruitingPhase 4
The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression
The Effects of Lumateperone on Obesity and Physiologic Aging and Their Correlation With Antidepressant Response in Bipolar Depression
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 7 Jul 2026
- Start date
- 9 Sept 2026
- Primary completion date
- 31 Jan 2028
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Obesity, Bipolar disorder
- NCT number
- NCT07699445
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 25
- From 9 Sept 2026 to the primary completion date, 31 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior treatment with lumateperone.
- Current treatment with strong or moderate CYP3A4 inhibitors or CYP3A4 inducers.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.