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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 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.

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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.

Conditions Studied

Major Depressive Disorder (MDD) Major Depressive Disorder With Anxious Distress

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

FieldValue
Enrollment Target 360 participants
Start Date 2025-06-19
Est. Completion 2027-03
Phase Phase 2

Sponsor

Seaport Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07065240

The ClinicalTrials.gov registry entry for NCT07065240 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 142-participant average among 22 other Major Depressive Disorder (MDD) trials with a reported enrollment target (154% higher). The listed sponsor is Seaport Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.