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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: Recruiting Phase 2 study of Major Depressive Disorder, sponsored by Syndeio Biosciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
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
- 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
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2026-01-05 |
| Est. Completion | 2028-06 |
| Phase | Phase 2 |
What NCT07115329 shows while recruiting
NCT07115329 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.
NCT07115329 names 20 study sites across 9 states, led by 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.
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 NCT07115329'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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