Sequential Multiple Assignment Randomized Trial for Bipolar Depression (NCT06433635)
๐ฉบ Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: University of Alabama Birmingham โ Birmingham, Alabama
Age range: 18 Years to 75 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (18 Sites)
- University of Alabama Birmingham โ Birmingham, Alabama
- Steve Strakowski โ Bloomington, Indiana
- John Hopkins โ Baltimore, Maryland
- McLean Hospital โ Belmont, Massachusetts
- Massachusetts General Hospital โ Boston, Massachusetts
- University of Michigan โ Ann Arbor, Michigan
- Nagy Youssef โ Grand Rapids, Michigan
- University of New Mexico Health Sciences Center Albuquerque โ Albuquerque, New Mexico
- New York University Grossman School of Medicine NYU โ New York, New York
- Montefiore Medical Center and Albert Einstein College of Medicine โ New York, New York
- University of North Carolina at Chapel Hill โ Chapel Hill, North Carolina
- Case Western Reserve University โ Cleveland, Ohio
- University of Pennsylvania โ Philadelphia, Pennsylvania
- University of Pittsburgh โ Pittsburgh, Pennsylvania
- University of Texas at Austin โ Austin, Texas
- UT Southwestern Medical Center โ Dallas, Texas
- UT Health Houston Texas โ Houston, Texas
- University of British Columbia โ Vancouver, British Columbia
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Bipolar I Disorder clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.