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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Syndeio Biosciences, Inc
Study ID
NCT06547489
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 3, 2025
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
164 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: zelquistinel (GATE-251)
    zelquistinel (GATE-251) will be administered as a single 10 mg oral tablet one time each week for 6 weeks.
  • Placebo Comparator: Placebo
    Placebo tablet identical in appearance to the experimental treatment tablet, administered as as a single oral tablet one time each week for 6 weeks.

Primary Outcome Measure

Change in the Hamilton Depression Rating Scale-17 (HDRS-17) score compared to placebo [ Time Frame: Change in score from predose baseline to end of week 6 ]

Central Contacts

Locations (34)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
University of Alabama at Birmingham-HuntsvilleHuntsvilleAlabama35801-
Wr-Pri, LlcEncinoCalifornia91316-
Irvine Clinical ResearchIrvineCalifornia92614-
CalNeuro Research GroupLos AngelesCalifornia90025-
Pacific Clinical Research Management Group LLCUplandCalifornia91786-
Sunwise Clinical Research LLCWalnut CreekCalifornia94549-
MCB Clinical Research Centers, Inc.Colorado SpringsColorado80910-
Mountain View Clinical ResearchDenverColorado80209-
University of Connecticut School of Medicine Psychiatry DepartmentFarmingtonConnecticut06030-
Clinical Neuroscience Solutions, Inc.JacksonvilleFlorida32256-
D&H Pompano Research Center, LLCMargateFlorida33063-
Miami Dade Medical Research InstituteMiamiFlorida33176-
Premier Clinical Research Institute, Inc.MiamiFlorida33122-
Clinical Neuroscience Solutions, Inc.OrlandoFlorida32801-
CenExel iRS (iResearch Savannah)SavannahGeorgia31405-
Revive Research InstituteElginIllinois60123-
KUMC-WichitaWichitaKansas66160-
Quantum Research Associates Corp.LouisvilleKentucky40218-
Boston Clinical TrialsBostonMassachusetts02131-
Mayflower ClinicalRussells MillsMassachusetts02747-
Vector Clinical TrialsLas VegasNevada89128-
Neurobehavioral Research, Inc.CedarhurstNew York11516-
Insight Clinical Trials LLCIndependenceOhio44131-
Sooner Clinical Research, Inc.Oklahoma CityOklahoma73116-
Lehigh Center for Clinical ResearchAllentownPennsylvania18103-
Clinical Neuroscience Solutions, Inc.MemphisTennessee38119-
Austin Clinical Trial PartnersAustinTexas78737-
InSite Clinical Research, LLCDeSotoTexas75115-
Baylor College of Medicine, Psychiatry and Behavioral SciencesHoustonTexas77030-
Clinical Trials of Texas LLCSan AntonioTexas78229-
Grayline Research CenterWichita FallsTexas76309-
Andes Clinical ResearchOremUtah84097-
Northwest Clinical Research CenterBellevueWashington98007-

Find similar trials in Birmingham, AL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of Alabama at Birmingham-Huntsville· Huntsville, ALWr-Pri, Llc· Encino, CAIrvine Clinical Research· Irvine, CACalNeuro Research Group· Los Angeles, CAPacific Clinical Research Management Group LLC· Upland, CA

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