๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-01

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression) (NCT07172516)

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Xenon Pharmaceuticals Inc.

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

X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).

Who can join: Review the eligibility criteria below.

Location: Noble Clinical Research โ€” Tucson, Arizona

Age range: 18 Years to 74 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 (28 Sites)

Showing the first 25 of 28 sites.

  • Noble Clinical Research โ€” Tucson, Arizona
  • Woodland International Research Group โ€” Little Rock, Arkansas
  • Woodland Research Northwest โ€” Rogers, Arkansas
  • Clinical Innovations Inc โ€” Bellflower, California
  • ProScience Research Group โ€” Culver City, California
  • ATP Clinical Research โ€” Orange, California
  • NRC Research Institute โ€” Orange, California
  • Clinical Innovations Inc โ€” Riverside, California
  • PharmaSouth Research, LLC โ€” Coral Gables, Florida
  • Clinical Neuroscience Solutions, Inc. โ€” Jacksonville, Florida
  • Central Miami Medical Institute โ€” Miami, Florida
  • Clinical Neuroscience Solutions, Inc โ€” Orlando, Florida
  • Synexus Clinical Research, Inc. โ€” Atlanta, Georgia
  • Atlanta Center for Medical Research โ€” Atlanta, Georgia
  • CenExel iResearch โ€” Decatur, Georgia
  • Denali Health Atlanta, LLC โ€” Stone Mountain, Georgia
  • Advanced Quality Medical Research โ€” Orland Park, Illinois
  • Psychiatric Care and Research Center โ€” O'Fallon, Missouri
  • Redbird Clinical Research, LLC โ€” Las Vegas, Nevada
  • Lumina Clinical Research Center โ€” Cherry Hill, New Jersey
  • Integrative Clinical Trials LLC โ€” Brooklyn, New York
  • Neurobehavioral Research Inc โ€” Cedarhurst, New York
  • DelRicht Research โ€” Charlotte, North Carolina
  • Lehigh Center for Clinical Research โ€” Allentown, Pennsylvania
  • Clinical Neuroscience Solutions, Inc โ€” Memphis, Tennessee

๐Ÿ“ž Contact the Study Coordinator

Phone: (604) 484-3300

Email: XenonCares@xenon-pharma.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.

Explore by condition: All Bipolar Disorder clinical trials

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†—