๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-23

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder (NCT07115329)

Phase 2, Multicenter, Randomized, Double-Blind Evaluation of the Efficacy and Safety of Oral GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Syndeio Biosciences, Inc

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

The goal of this clinical trial is to learn if zelquistinel works to treat depression in adults. It will also learn about the safety of zelquistinel. The main questions it aims to answer are: Does zelquistinel reduce depression scores in participants compared to participants who take a placebo (a look-alike tablet that contains no zelquistinel1)? What medical problems are observed in participants who take zelquistinel? Participants will take one tablet of zelquistinel or placebo every week for 6 weeks. Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated.

Who can join: Review the eligibility criteria below.

Location: NoesisPharma, LLC โ€” Phoenix, Arizona

Age range: 18 Years to 64 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 (32 Sites)

Showing the first 25 of 32 sites.

  • NoesisPharma, LLC โ€” Phoenix, Arizona
  • Del Sol Research Management โ€” Tucson, Arizona
  • Catalina Research Institute, LLC โ€” Montclair, California
  • Excell Research, Inc โ€” Oceanside, California
  • Anderson Clinical Research โ€” Redlands, California
  • Studyops Inc โ€” San Francisco, California
  • Lumos Clinical Research Center โ€” San Jose, California
  • Sunwise Clinical Research โ€” Walnut Creek, California
  • Clinical Neuroscience Solutions, Inc โ€” Jacksonville, Florida
  • Premier Clinical Research Institute Inc โ€” Miami, Florida
  • Aqualane Clinical Research โ€” Naples, Florida
  • EquiPath Health and Research Tampa Bay, LLC โ€” Riverview, Florida
  • Neuroscience Research Institute โ€” West Palm Beach, Florida
  • Denali Health Atlanta, LLC โ€” Stone Mountain, Georgia
  • EmVenio Research โ€” Chicago, Illinois
  • Tandem Clinical Research โ€” Metairie, Louisiana
  • Sunstone Therapies โ€” Rockville, Maryland
  • Continental Clinical Solutions โ€” Towson, Maryland
  • Vitalix Clinical โ€” Worcester, Massachusetts
  • Rochester Center for Behavioral Medicine โ€” Rochester Hills, Michigan
  • Neurobehavioral Research, Inc โ€” Cedarhurst, New York
  • IMA Clinical Research - NYC Midtown โ€” New York, New York
  • IMA Clinical Research - NYC Uptown โ€” New York, New York
  • UNC Health Rex โ€” Raleigh, North Carolina
  • Insight Clinical Trials LLC โ€” Independence, Ohio

๐Ÿ“ž Contact the Study Coordinator

Phone: (781) 786-1545

Email: karen.raudibaugh@syndeio.bio

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†—