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RECRUITING Phase 2

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

NCT06547489 · 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 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.

Conditions Studied

Interventions

  • DRUG Zelquistinel

Study Locations (20)

California

  • Wr-Pri, Llc — Encino
  • Irvine Clinical Research — Irvine
  • CalNeuro Research Group — Los Angeles
  • Pacific Clinical Research Management Group LLC — Upland
  • Sunwise Clinical Research LLC — Walnut Creek

Florida

  • Clinical Neuroscience Solutions, Inc. — Jacksonville
  • D&H Pompano Research Center, LLC — Margate
  • Premier Clinical Research Institute, Inc. — Miami
  • Miami Dade Medical Research Institute — Miami
  • Clinical Neuroscience Solutions, Inc. — Orlando

Alabama

  • University of Alabama at Birmingham — Birmingham
  • University of Alabama at Birmingham-Huntsville — Huntsville

Colorado

  • MCB Clinical Research Centers, Inc. — Colorado Springs
  • Mountain View Clinical Research — Denver

Connecticut

  • University of Connecticut School of Medicine Psychiatry Department — Farmington

Georgia

  • CenExel iRS (iResearch Savannah) — Savannah

Illinois

  • Revive Research Institute — Elgin

Kansas

  • KUMC-Wichita — Wichita

Trial Details

FieldValue
Enrollment Target 164 participants
Start Date 2025-02-03
Est. Completion 2027-12
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 NCT06547489

The ClinicalTrials.gov registry entry for NCT06547489 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: NCT06547489 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Alabama. 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 NCT06547489 about?

NCT06547489 is a clinical study titled "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 NCT06547489?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2025-02-03. Estimated completion is 2027-12.

What conditions does trial NCT06547489 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 NCT06547489?

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 NCT06547489?

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 NCT06547489 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. 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