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NCT06547489 · ClinicalTrials.gov registry record · Phase 2
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
NCT06547489: Recruiting Phase 2 study of Major Depressive Disorder, sponsored by Syndeio Biosciences.
NCT06547489 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 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06547489, 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 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.
Primary Outcome
HDRS-17 is used to assess the severity of depression. The range of scores for the HDRS-17 is 0 - 52 with lower scores indicating a better outcome
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
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2025-02-03 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT06547489 shows while recruiting
NCT06547489 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (56% lower).
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.
NCT06547489 names 20 study sites across 10 states, led by California, Florida, Alabama.
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.
What interventions are being tested in trial NCT06547489?
The interventions under investigation include: Zelquistinel (DRUG).
Who is sponsoring clinical trial NCT06547489?
This trial is sponsored by Syndeio Biosciences, which has 7 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06547489's enrollment target sits among peer trials
164 92nd of 282 higher than 190 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder
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A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
RECRUITING · Phase 2
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