Clinical Trial

Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

Study acronym: GATE-251
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
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 zelquistinel)? 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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2024-08-07; most recent amendment 2026-07-02.
Status change: Not Yet Recruiting → Recruiting 2025-01-14
Trial Details
NCT Number NCT06547489
Lead Sponsor Syndeio Biosciences, Inc
Collaborators: Worldwide Clinical Trials
Conditions Major Depressive Disorder
Enrollment 164 participants
Start Date 2025-02-03
Primary Completion 2027-09 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-03