Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 28, 2024

Keywords

ClinConnect Summary

This is a comparative effectiveness study to address the critical questions of how best to treat people with bipolar disorder who have a major depressive episode: how to get them well, provide second-line treatment when they don't initially get well, and keep them well after they get well. This is a multisite Sequential Multiple Assignment Randomized Trial (SMART) comparative effectiveness design. Investigators will recruit 2726 participants who have BD with a current major depressive episode. In Stage 1, investigators will compare four treatment arms, including three FDA approved monothera...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged between 18 years to 75 years
• • 2. Meets criteria for DSM-V Bipolar I disorder with a history of manic episodes and current major depressive episode lasting at least 6 weeks
• • 3. Can be managed as an outpatient and participate in the study
• • 4. Willing to be randomized; able to perform study assessments
• • 5. Women of childbearing potential must agree to use adequate contraception (e.g. oral contraceptives, intrauterine device, barrier methods, or total abstinence; Depo Provera is acceptable if it is started 3 months prior to enrollment), and inform staff of their plans to conceive.
• Exclusion Criteria:
• • 1. Meets current criteria for a manic episode, rapid cycling within the past year (history of 4 or more mood episodes per year)
• • 2. History of schizophrenia or other nonaffective psychosis
• • 3. Current substance use disorder that will interfere with participation in the study
• • 4. Currently taking the study medications or a history of serious adverse events to any of the study medications, to the extent that as determined by site PI, another trial would not be clinically indicated
• • 5. A history of non-response for depressive episodes, to any of the study medications, when given at adequate doses for at least 6 weeks
• • 6. Current acute suicidal risk that requires inpatient treatment
• • 7. Pregnancy or breastfeeding