๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-01-21

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms (NCT06223880)

A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms

๐ŸŸข Recruiting Phase4 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Axsome Therapeutics, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.

Who can join: Review the eligibility criteria below.

Location: Clinical Research Site โ€” Bellflower, California

Age range: 18 Years to 65 Years

๐Ÿงช Interventions in This Study

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 (40 Sites)

Showing the first 25 of 40 sites.

  • Clinical Research Site โ€” Bellflower, California
  • Clinical Research Site โ€” Lafayette, California
  • Clinical Research Site โ€” Oceanside, California
  • Clinical Research Site โ€” Redlands, California
  • Clinical Research Site โ€” Riverside, California
  • Clinical Research Site โ€” San Diego, California
  • Clinical Research Site โ€” Upland, California
  • Clinical Research Site โ€” Brandon, Florida
  • Clinical Research Site โ€” Doral, Florida
  • Clinical Research Site โ€” Hialeah, Florida
  • Clinical Research Site โ€” Jacksonville, Florida
  • Clinical Research Site โ€” Miami, Florida
  • Clinical Research Site โ€” Orlando, Florida
  • Clinical Research Site โ€” Orlando, Florida
  • Clinical Research Site โ€” Orlando, Florida
  • Clinical Research Site โ€” Atlanta, Georgia
  • Clinical Research Site โ€” Chicago, Illinois
  • Clinical Research Site โ€” Overland Park, Kansas
  • Clinical Research Site โ€” New Orleans, Louisiana
  • Clinical Research Site โ€” Boston, Massachusetts
  • Clinical Research Site โ€” Saint Charles, Missouri
  • Clinical Research Site โ€” Las Vegas, Nevada
  • Clinical Research Site โ€” Cherry Hill, New Jersey
  • Clinical Research Site โ€” Toms River, New Jersey
  • Clinical Research Site โ€” Brooklyn, New York

๐Ÿ“ž Contact the Study Coordinator

Phone: (212) 332-5061

Email: axs-05-mdd-401@axsome.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

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. Contact the study coordinator using the phone/email above.
  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†—