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NCT07065240 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)
A Phase 2 study of Major Depressive Disorder (MDD) and Major Depressive Disorder With Anxious Distress, sponsored by Seaport Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT07065240: Recruiting Phase 2 study of Major Depressive Disorder (MDD) and Major Depressive Disorder With Anxious Distress, sponsored by Seaport Therapeutics.
NCT07065240 is a Phase 2 study of Major Depressive Disorder (MDD) and Major Depressive Disorder With Anxious Distress that is actively recruiting participants, run by Seaport Therapeutics. The registered enrollment target is 360 participants, above the 142-participant average among 22 other Major Depressive Disorder (MDD) trials with a reported enrollment target (154% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07065240, a Phase 2 study of Major Depressive Disorder (MDD) and Major Depressive Disorder With Anxious Distress, is actively recruiting participants, sponsored by Seaport Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 360 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.
Primary Outcome
HAM-D-17 is a 17-item, clinician-administered rating scale to assess the severity of symptoms in participants diagnosed with depression. The HAM-D-17 comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), s
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SPT-300
Study Locations (20)
California
- Seaport Investigator Site - Chino
- Seaport Investigator Site - Garden Grove
- Seaport Investigator Site - Glendale
Georgia
- Seaport Investigator Site - Atlanta
- Seaport Investigator Site - Decatur
- Seaport Investigator Site - Marietta
New York
- Seaport Investigator Site - Brooklyn
- Seaport Investigator Site - New York
- Seaport Investigator Site - Staten Island
Other
- Seaport Investigator Site - Plovdiv
- Seaport Investigator Site - Sofia
- Seaport Investigator Site - Sofia
Massachusetts
- Seaport Investigator Site - Boston
- Seaport Investigator Site - Boston
Ohio
- Seaport Investigator Site - Independence
- Seaport Investigator Site - North Canton
Connecticut
- Seaport Investigator Site - Cromwell
Florida
- Seaport Investigator Site - West Palm Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2025-06-19 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What NCT07065240 shows while recruiting
NCT07065240 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, above the 142-participant average among 22 other Major Depressive Disorder (MDD) trials with a reported enrollment target (154% higher).
The record links to 2 conditions, with Major Depressive Disorder (MDD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07065240 names 20 study sites across 10 states, led by California, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT07065240 about?
NCT07065240 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)". This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.
What is the current status of trial NCT07065240?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2025-06-19. Estimated completion is 2027-03.
What conditions does trial NCT07065240 study?
This clinical trial studies the following conditions: Major Depressive Disorder (MDD), Major Depressive Disorder With Anxious Distress.
What interventions are being tested in trial NCT07065240?
The interventions under investigation include: Placebo (DRUG), SPT-300 (DRUG).
Who is sponsoring clinical trial NCT07065240?
This trial is sponsored by Seaport Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07065240 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder (MDD)
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 NCT07065240's enrollment target sits among peer trials
360 3rd of 22 higher than 20 of 22 other Major Depressive Disorder (MDD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder (MDD) 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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