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New depression drug SPT-300 moves to safety testing in extension trial

NCT ID NCT07161700

Symptom relief Sponsor: Seaport Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 18, 2026 · Updated 5 times

Summary

This study is an extension of an earlier trial, testing the safety and tolerability of SPT-300 in 360 adults with major depressive disorder, with or without anxious distress. Participants who completed the prior study will receive SPT-300 for 6 weeks. The goal is to monitor side effects and see if the drug is safe enough for further development.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SPT-300 (a prodrug of allopregnanolone)
What this could lead to
If successful, this could point toward a new treatment option for major depressive disorder that may ease symptoms with a different mechanism than current antidepressants.
What could go wrong
This is an early-phase, open-label extension study with no placebo group, so results may be biased. It focuses on safety, not effectiveness, and the drug may still fail in larger trials or cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 66 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant who completed treatment in Study SPT-300-2024-203 (i.e., participant who competed Visit 8 \[Day 42\] of Study SPT-300-2024-203 \[BUOY-1 Study\]). * Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP must agree to use a highly effective form of contraception during participation in the study and for 30 days after receiving the last dose of study treatment. * Participant is willing and able to refrain from the use of drugs of abuse. Exclusion Criteria: * Participants who, in the opinion of the Investigator, medical monitor, or Sponsor, should not participate in the study. * Participants who, in the judgment of the Investigator, were noncompliant with trial procedures or with study treatment administration during the double-blind study (BUOY-1 Study). * Female participants with a positive urine pregnancy test result. Female participants may be enrolled without a negative urine test if they are surgically sterile or at least 2 years post-menopause.

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Conditions

The condition(s) this trial relates to.

anxiety disorder Depression depressive disorder major depressive disorder mood disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder (MDD) Major depressive disorder with anxious distress

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    40 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Seaport Investigator Site

    Chino, California, 91710, United States

  • Seaport Investigator Site

    Garden Grove, California, 92845-2506, United States

  • Seaport Investigator Site

    Glendale, California, 91206, United States

  • Seaport Investigator Site

    San Jose, California, 95124, United States

  • Seaport Investigator Site

    Cromwell, Connecticut, 06416, United States

  • Seaport Investigator Site

    Lauderhill, Florida, 33319, United States

  • Seaport Investigator Site

    Palm Bay, Florida, 32905, United States

  • Seaport Investigator Site

    West Palm Beach, Florida, 33407, United States

  • Seaport Investigator Site

    Atlanta, Georgia, 30328, United States

  • Seaport Investigator Site

    Decatur, Georgia, 30030, United States

  • Seaport Investigator Site

    Boston, Massachusetts, 02116, United States

  • Seaport Investigator Site

    St Louis, Missouri, 63141, United States

  • Seaport Investigator Site

    Brooklyn, New York, 11235, United States

  • Seaport Investigator Site

    Cedarhurst, New York, 11516, United States

  • Seaport Investigator Site

    New York, New York, 10029, United States

  • Seaport Investigator Site

    Staten Island, New York, 10314, United States

  • Seaport Investigator Site

    Independence, Ohio, 44131, United States

  • Seaport Investigator Site

    North Canton, Ohio, 44720, United States

  • Seaport Investigator Site

    Irving, Texas, 75062, United States

  • Seaport Investigator Site

    Plovdiv, 4004, Bulgaria

  • Seaport Investigator Site

    Sofia, 1000, Bulgaria

  • Seaport Investigator Site

    Brno, 602 00, Czechia

  • Seaport Investigator Site

    Prague, 100 00, Czechia

  • Seaport Investigator Site

    Prague, 110 00, Czechia

  • Seaport Investigator Site

    Prague, 160 00, Czechia

  • Seaport Investigator Site

    Prague, 186 00, Czechia

  • Seaport Investigator Site

    Berlin, Brandenburg, D-10629, Germany

  • Seaport Investigator Site

    Schwerin, Mecklenburg-Vorpommern, 19053, Germany

  • Seaport Investigator Site

    Chemnitz, 09111, Germany

  • Seaport Investigator Site

    Budapest, 1033, Hungary

  • Seaport Investigator Site

    Budapest, 1134, Hungary

  • Seaport Investigator Site

    Bialystok, 15-404, Poland

  • Seaport Investigator Site

    Bialystok, 15-464, Poland

  • Seaport Investigator Site

    Bydgoszcz, 85-080, Poland

  • Seaport Investigator Site

    Gdansk, 80-438, Poland

  • Seaport Investigator Site

    Leszno, 64-100, Poland

  • Seaport Investigator Site

    Poznan, 60-744, Poland

  • Seaport Investigator Site

    Tuszyn, 95-080, Poland

  • Seaport Investigator Site

    Rimavská Sobota, 979 01, Slovakia

  • Seaport Investigator Site

    Vranov nad Topľou, 09301, Slovakia

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