NCT06433635Active, not recruitingPhase 4
Sequential Multiple Assignment Randomized Trial for Bipolar Depression
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 2726 (estimated)
- First submitted
- 22 Apr 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 28 Feb 2030
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Bipolar disorder
- NCT number
- NCT06433635
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 2726
- From 1 Oct 2024 to the primary completion date, 28 Feb 2030
- 18 sites in 2 countries
- 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
- 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
Other illness
- Meets current criteria for a manic episode, rapid cycling within the past year (history of 4 or more mood episodes per year)
- History of schizophrenia or other nonaffective psychosis
- Current substance use disorder that will interfere with participation in the study
- A history of non-response for depressive episodes, to any of the study medications, when given at adequate doses for at least 6 weeks
Other
- Current acute suicidal risk that requires inpatient treatment
- Pregnancy or breastfeeding
Who the study is looking for
- Aged between 18 years to 75 years
- Meets criteria for DSM-V Bipolar I or II disorder with a history of manic or hypomanic episodes and current major depressive episode lasting at least 2 weeks
- Can be managed as an outpatient and participate in the study
- Willing to be randomized; able to perform study assessments
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| University of New Mexico Health Sciences Center Albuquerque Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of Texas at Austin Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| John Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Unknown status |
| University of Alabama Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Steve Strakowski Coordinator of this site? Confirm its status | Bloomington | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Case Western Reserve University Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Nagy Youssef Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| UT Health Houston Texas Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Montefiore Medical Center and Albert Einstein College of Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| New York University Grossman School of Medicine NYU Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.