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RECRUITING Phase 2

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

NCT07115329 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Zelquistinel

Study Locations (20)

California

  • Catalina Research Institute, LLC — Montclair
  • Excell Research, Inc — Oceanside
  • Anderson Clinical Research — Redlands
  • Studyops Inc — San Francisco
  • Lumos Clinical Research Center — San Jose
  • Sunwise Clinical Research — Walnut Creek

Florida

  • Clinical Neuroscience Solutions, Inc — Jacksonville
  • Premier Clinical Research Institute Inc — Miami
  • Aqualane Clinical Research — Naples
  • EquiPath Health and Research Tampa Bay, LLC — Riverview
  • Neuroscience Research Institute — West Palm Beach

Arizona

  • NoesisPharma, LLC — Phoenix
  • Del Sol Research Management — Tucson

Maryland

  • Sunstone Therapies — Rockville
  • Continental Clinical Solutions — Towson

Georgia

  • Denali Health Atlanta, LLC — Stone Mountain

Illinois

  • EmVenio Research — Chicago

Louisiana

  • Tandem Clinical Research — Metairie

Massachusetts

  • Vitalix Clinical — Worcester

Trial Details

FieldValue
Enrollment Target 164 participants
Start Date 2026-01-05
Est. Completion 2028-06
Phase Phase 2

Sponsor

Syndeio Biosciences

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07115329

The ClinicalTrials.gov registry entry for NCT07115329 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Syndeio Biosciences, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention — of which Zelquistinel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07115329 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07115329 about?

NCT07115329 is a clinical study titled "A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder". 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 l...

What is the current status of trial NCT07115329?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2026-01-05. Estimated completion is 2028-06.

What conditions does trial NCT07115329 study?

This clinical trial studies the following conditions: Major Depressive Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07115329?

The interventions under investigation include: Zelquistinel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07115329?

This trial is sponsored by Syndeio Biosciences, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07115329 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial