Clinical trialNCT06547489RecruitingPhase 2Interventional

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

SponsorSyndeio Biosciences, IncEnrollment164Major Depressive Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Aaron Koenig, MD
Syndeio Biosciences
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

34 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama at Birmingham
Birmingham, Alabama, United States
Recruiting
University of Alabama at Birmingham-Huntsville
Huntsville, Alabama, United States
Active, not recruiting
Wr-Pri, Llc
Encino, California, United States
Withdrawn
Irvine Clinical Research
Irvine, California, United States
Recruiting
Calneuro Research Group
Los Angeles, California, United States
Recruiting
Pacific Clinical Research Management Group Llc
Upland, California, United States
Terminated
Sunwise Clinical Research Llc
Walnut Creek, California, United States
Recruiting
Mcb Clinical Research Centers, Inc.
Colorado Springs, Colorado, United States
Recruiting
Mountain View Clinical Research
Denver, Colorado, United States
Recruiting
University of Connecticut School of Medicine Psychiatry Department
Farmington, Connecticut, United States
Recruiting
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Recruiting
D&h Pompano Research Center, Llc
Margate, Florida, United States
Recruiting
Miami Dade Medical Research Institute
Miami, Florida, United States
Recruiting
Premier Clinical Research Institute, Inc.
Miami, Florida, United States
Recruiting
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Recruiting
Cenexel Irs (iresearch Savannah)
Savannah, Georgia, United States
Recruiting
Revive Research Institute
Elgin, Illinois, United States
Withdrawn
Kumc-Wichita
Wichita, Kansas, United States
Withdrawn
Quantum Research Associates Corp.
Louisville, Kentucky, United States
Active, not recruiting
Boston Clinical Trials
Boston, Massachusetts, United States
Withdrawn
Mayflower Clinical
Russells Mills, Massachusetts, United States
Recruiting
Vector Clinical Trials
Las Vegas, Nevada, United States
Active, not recruiting
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Recruiting
Insight Clinical Trials Llc
Independence, Ohio, United States
Recruiting
Sooner Clinical Research, Inc.
Oklahoma City, Oklahoma, United States
Withdrawn
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Recruiting
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Withdrawn
Austin Clinical Trial Partners
Austin, Texas, United States
Recruiting
Insite Clinical Research, Llc
DeSoto, Texas, United States
Recruiting
Baylor College of Medicine, Psychiatry and Behavioral Sciences
Houston, Texas, United States
Withdrawn
Clinical Trials of Texas Llc
San Antonio, Texas, United States
Withdrawn
Grayline Research Center
Wichita Falls, Texas, United States
Recruiting
Andes Clinical Research
Orem, Utah, United States
Recruiting
Northwest Clinical Research Center
Bellevue, Washington, United States
Withdrawn

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Zelquistinel

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 3 Feb 2025
Primary completion: 30 Sept 2027
Completion: 31 Dec 2027
Last update posted: 3 Aug 2026
Registered enrollment: 164
Registry id: NCT06547489

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.