The Effects of Lumateperone on Obesity and Physiologic Aging and Their Correlation With Antidepressant Response in Bipolar Depression
Massachusetts General Hospital
Summary
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 sympto…
Interventions
- DrugLumateperone 42 mg
Lumateperone 42 mg orally daily
Location
- Massachusetts General HospitalBoston, Massachusetts