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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
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

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of British Columbia
Coordinator of this site? Confirm its status
VancouverCanadaUnknown status
University of New Mexico Health Sciences Center Albuquerque
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AlbuquerqueUnited StatesUnknown status
University of Michigan
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Ann ArborUnited StatesUnknown status
University of Texas at Austin
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AustinUnited StatesUnknown status
John Hopkins
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BaltimoreUnited StatesUnknown status
McLean Hospital
Coordinator of this site? Confirm its status
BelmontUnited StatesUnknown status
University of Alabama Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Steve Strakowski
Coordinator of this site? Confirm its status
BloomingtonUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
University of North Carolina at Chapel Hill
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Chapel HillUnited StatesUnknown status
Case Western Reserve University
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ClevelandUnited StatesUnknown status
UT Southwestern Medical Center
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DallasUnited StatesUnknown status
Nagy Youssef
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Grand RapidsUnited StatesUnknown status
UT Health Houston Texas
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HoustonUnited StatesUnknown status
Montefiore Medical Center and Albert Einstein College of Medicine
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New YorkUnited StatesUnknown status
New York University Grossman School of Medicine NYU
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New YorkUnited StatesUnknown status
University of Pennsylvania
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PhiladelphiaUnited StatesUnknown status
University of Pittsburgh
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PittsburghUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.