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NCT07115329 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Major Depressive Disorder, sponsored by Syndeio Biosciences.

Recruiting
Registry status
Phase 2
Development phase
164
Enrollment target
20
Study locations

NCT07115329 is a Phase 2 study of Major Depressive Disorder that is actively recruiting participants, run by Syndeio Biosciences. The registered enrollment target is 164 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT07115329, a Phase 2 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Syndeio Biosciences.

RECRUITING
Registry status
Phase 2
Development phase
164 participants
Enrollment target
20
Study locations

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

7 total trials

What the Registry Record Tells You About NCT07115329

The ClinicalTrials.gov registry entry for NCT07115329 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (56% lower). The listed sponsor is Syndeio Biosciences, which has 7 total studies on file at ClinicalTrials.gov.

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.

NCT07115329 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Florida, Arizona.

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.

What interventions are being tested in trial NCT07115329?

The interventions under investigation include: Zelquistinel (DRUG).

Who is sponsoring clinical trial NCT07115329?

This trial is sponsored by Syndeio Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.

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.

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

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