Sequential Multiple Assignment Randomized Trial for Bipolar Depression

Running, not enrolling · Phase 4 · Has a placebo group

Conditions studied: Bipolar I Disorder, Depression

In brief

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).

Key facts

Study ID

NCT06433635

Run by

Massachusetts General Hospital

People needed

2726

Starts

2024-10-01

Expected to finish

2030-02-28

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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
• A history of non-response for depressive episodes, to any of the study medications, when given at adequate doses for at least 6 weeks
• Current acute suicidal risk that requires inpatient treatment
• Pregnancy or breastfeeding

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Steve Strakowski — Bloomington, Indiana, United States
• John Hopkins — Baltimore, Maryland, United States
• McLean Hospital — Belmont, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Nagy Youssef — Grand Rapids, Michigan, United States
• University of New Mexico Health Sciences Center Albuquerque — Albuquerque, New Mexico, United States
• New York University Grossman School of Medicine NYU — New York, New York, United States
• Montefiore Medical Center and Albert Einstein College of Medicine — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas at Austin — Austin, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• UT Health Houston Texas — Houston, Texas, United States
• University of British Columbia — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.