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

Detailed 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 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

Drug
Lumateperone 42 mg
Lumateperone 42 mg orally daily

Location

Massachusetts General Hospital
Boston, Massachusetts
mhenry14@mgh.harvard.edu 6176435750

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

Summary

Eligibility

Interventions

Location

Compensation

Run this study?

Details

Conditions