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RECRUITING 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)

NCT07065240 · View on ClinicalTrials.gov ↗

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.

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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seaport Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07065240 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Georgia, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07065240?

The interventions under investigation include: Placebo (DRUG), SPT-300 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07065240?

This trial is sponsored by Seaport Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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