๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-12-10

Sequential Multiple Assignment Randomized Trial for Bipolar Depression (NCT06433635)

๐Ÿ”ต Active, Not Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Massachusetts General Hospital

๐Ÿฉบ 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

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ 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

๐Ÿ’ฐ 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—