Zelquistinel for Major Depressive Disorder

This study is testing a drug called zelquistinel to see if it can help reduce symptoms of major depressive disorder (MDD) in adults. Researchers also want to understand its safety. You might be able to join if you are between 18 and 64 years old and have been diagnosed with MDD. The main goal is to see if zelquistinel lowers depression scores more than a placebo (a pill with no medicine). Participants will take either zelquistinel or a placebo once a week for 6 weeks. Your depression symptoms will be checked weekly during this time.

Study design
This is a Phase 2 study that will involve about 164 participants. It is randomized and double-blind, meaning you won't know if you're getting zelquistinel or a placebo, and neither will your study doctor.
What's involved
You will participate in the study for up to 98 days, including screening, 6 weeks of treatment, and a 4-week follow-up. You will visit the clinic once a week during the 6-week treatment period to have your depression assessed.
Compensation
Not stated in the trial record.
Follow-up
After the 6 weeks of treatment, there will be a 4-week follow-up period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06547489

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

Recruiting
PHASE2Ages 18–64InterventionalTreatment
Syndeio Biosciences, Inc
~164 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Zelquistinel

At a glance

Recruiting sites
21 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in the Hamilton Depression Rating Scale-17 (HDRS-17) score compared to placebo
Measured over Change in score from predose baseline to end of week 6
Major Depressive Disorder
34 sites across 19 states
California5
Florida5
Texas5
Alabama2
Colorado2
Massachusetts2
Connecticut1
Georgia1
  • Aaron Koenig, MD · STUDY_CHAIR · Syndeio Biosciences

Opens a ready-to-send draft in your own email app — review before sending.

  • Change in the Hamilton Depression Rating Scale-17 (HDRS-17) score compared to placeboChange in score from predose baseline to end of week 6

    HDRS-17 is used to assess the severity of depression. The range of scores for the HDRS-17 is 0 - 52 with lower scores indicating a better outcome