RecruitingPhase 2NCT07115329

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

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


Sponsor

Syndeio Biosciences, Inc

Enrollment

164 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called GATE-251 versus a placebo (inactive pill) for treating major depressive disorder (MDD) in adults who also have significant anxiety and sleep problems. The drug works on a different system in the brain compared to most antidepressants. **You may be eligible if...** - You are 18–64 years old - You have been diagnosed with major depression that has lasted 3 weeks to 18 months - You also have significant anxiety and insomnia symptoms (based on validated questionnaires) - You are not pregnant and agree to use contraception if of childbearing potential **You may NOT be eligible if...** - Your depression symptoms have changed significantly between your first and second screening visits - You do not meet the minimum severity thresholds for depression, anxiety, or insomnia on questionnaires - You have unstable psychiatric or medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGZelquistinel

Zelquistinel is a positive allosteric modulator of the N-Methyl-D-Aspartate (NMDA) receptor


Locations(32)

NoesisPharma, LLC

Phoenix, Arizona, United States

Del Sol Research Management

Tucson, Arizona, United States

Catalina Research Institute, LLC

Montclair, California, United States

Excell Research, Inc

Oceanside, California, United States

Anderson Clinical Research

Redlands, California, United States

Studyops Inc

San Francisco, California, United States

Lumos Clinical Research Center

San Jose, California, United States

Sunwise Clinical Research

Walnut Creek, California, United States

Clinical Neuroscience Solutions, Inc

Jacksonville, Florida, United States

Premier Clinical Research Institute Inc

Miami, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

EquiPath Health and Research Tampa Bay, LLC

Riverview, Florida, United States

Neuroscience Research Institute

West Palm Beach, Florida, United States

Denali Health Atlanta, LLC

Stone Mountain, Georgia, United States

EmVenio Research

Chicago, Illinois, United States

Tandem Clinical Research

Metairie, Louisiana, United States

Sunstone Therapies

Rockville, Maryland, United States

Continental Clinical Solutions

Towson, Maryland, United States

Vitalix Clinical

Worcester, Massachusetts, United States

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, United States

Neurobehavioral Research, Inc

Cedarhurst, New York, United States

IMA Clinical Research - NYC Midtown

New York, New York, United States

IMA Clinical Research - NYC Uptown

New York, New York, United States

UNC Health Rex

Raleigh, North Carolina, United States

Insight Clinical Trials LLC

Independence, Ohio, United States

Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Scranton Medical Institute, LLC

Moosic, Pennsylvania, United States

Adams Clinical

Philadelphia, Pennsylvania, United States

Psychiatric Consultants, PC

Franklin, Tennessee, United States

Elevate Synapsis, LLC

Atascocita, Texas, United States

Synapsis Bio

Atascocita, Texas, United States

Adams Clinical Dallas

DeSoto, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07115329


Related Trials