Clinical Trial

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Study acronym: SMART-BD
Active, Not Recruiting Phase 4
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Summary
This is a sequential multiple assignment randomized trial for adults (ages \> 18) with a bipolar disorder type 1 and type 2 diagnosis currently experiencing a depressive episode. It is a randomized pragmatic trial that will compare four commonly prescribed treatments for bipolar depression, which includes three FDA-approved medications (Cariprazine, Quetiapine and Lurasidone) and one antipsychotic/antidepressant combination (Aripiprazole/Escitalopram).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-05-28; most recent amendment 2025-12-10.
Status change: Recruiting → Active, Not Recruiting 2025-12-10
Status change: Not Yet Recruiting → Recruiting 2025-05-12
Trial Details
NCT Number NCT06433635
Lead Sponsor Massachusetts General Hospital
Collaborators: Patient-Centered Outcomes Research Institute
Conditions Bipolar I Disorder, Depression
Enrollment 2,726 participants
Start Date 2024-10-01
Primary Completion 2030-02-28 (estimated)
Study Completion 2030-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-12-16