RecruitingPhase 2NCT06547489

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

A 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 in Adults


Sponsor

Syndeio Biosciences, Inc

Enrollment

164 participants

Start Date

Feb 3, 2025

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 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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new experimental drug called GATE-251 (compared to a placebo/sugar pill) to see if it can reduce the symptoms of major depression. Major depressive disorder (MDD) is a serious mental health condition that causes persistent sadness, loss of interest, and other debilitating symptoms. The goal is to find out if GATE-251 is safe and effective at easing these symptoms. **You may be eligible if...** - You are between 18 and 64 years old - You have been formally diagnosed with major depressive disorder (MDD) - Your depressive episode has lasted at least 3 weeks but no longer than 18 months (if it's your first episode) - Your depression score on standard rating scales falls within the required range - You are not currently benefiting enough from existing antidepressant treatments **You may NOT be eligible if...** - You have bipolar disorder, schizophrenia, or certain other psychiatric conditions - You have a history of suicide attempts or active suicidal thoughts - You are currently taking certain medications that might interact with the study drug - You are pregnant or planning to become pregnant - You have significant liver, kidney, or heart problems - You have a history of substance abuse or dependence 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.

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Interventions

DRUGZelquistinel

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


Locations(34)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Alabama at Birmingham-Huntsville

Huntsville, Alabama, United States

Wr-Pri, Llc

Encino, California, United States

Irvine Clinical Research

Irvine, California, United States

CalNeuro Research Group

Los Angeles, California, United States

Pacific Clinical Research Management Group LLC

Upland, California, United States

Sunwise Clinical Research LLC

Walnut Creek, California, United States

MCB Clinical Research Centers, Inc.

Colorado Springs, Colorado, United States

Mountain View Clinical Research

Denver, Colorado, United States

University of Connecticut School of Medicine Psychiatry Department

Farmington, Connecticut, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

D&H Pompano Research Center, LLC

Margate, Florida, United States

Premier Clinical Research Institute, Inc.

Miami, Florida, United States

Miami Dade Medical Research Institute

Miami, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

CenExel iRS (iResearch Savannah)

Savannah, Georgia, United States

Revive Research Institute

Elgin, Illinois, United States

KUMC-Wichita

Wichita, Kansas, United States

Quantum Research Associates Corp.

Louisville, Kentucky, United States

Boston Clinical Trials

Boston, Massachusetts, United States

Mayflower Clinical

Russells Mills, Massachusetts, United States

Vector Clinical Trials

Las Vegas, Nevada, United States

Neurobehavioral Research, Inc.

Cedarhurst, New York, United States

Insight Clinical Trials LLC

Independence, Ohio, United States

Sooner Clinical Research, Inc.

Oklahoma City, Oklahoma, United States

Lehigh Center for Clinical Research

Allentown, Pennsylvania, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Austin Clinical Trial Partners

Austin, Texas, United States

InSite Clinical Research, LLC

DeSoto, Texas, United States

Baylor College of Medicine, Psychiatry and Behavioral Sciences

Houston, Texas, United States

Clinical Trials of Texas LLC

San Antonio, Texas, United States

Grayline Research Center

Wichita Falls, Texas, United States

Andes Clinical Research

Orem, Utah, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06547489


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