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New depression drug SPT-300 enters Mid-Stage trial

NCT ID NCT07065240

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 study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 15, 2026 · Updated 6 times

Summary

This study tests a new drug called SPT-300 in 360 adults with major depressive disorder, with or without anxiety. Participants will receive either the drug or a placebo for 6 weeks to see if it reduces depression symptoms. The goal is to find a safe and effective new treatment option.

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

Jun 2025

Expected to finish

Mar 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 65 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 is a male or female between 18 and 65 years of age, inclusive willing and able and have capacity to provide written informed consent. * Participants must have a primary diagnosis of MDD. Participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder (with or without agoraphobia) may be included if not the focus of treatment over the past 6 months prior to Screening and the Investigator considers MDD to be the primary diagnosis at Screening and Baseline. * Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening. * Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP agree to use an acceptable form of highly effective contraception during participation in the study and for 30 days after receiving the last dose of study treatment. * Body mass index (BMI) between 18 to 40 kg/m2, inclusive. * Participant is willing and able to refrain from the use of drugs of abuse. Exclusion Criteria: * History of, or current presentation consistent with: 1. any depressive episode with psychotic or catatonic features. 2. any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode. 3. bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression. 4. schizophrenia, schizoaffective, or other psychotic disorder. 5. obsessive-compulsive disorder. 6. any persistent neurocognitive disorder. * History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode. * Psychiatric hospitalization within current depressive episode. * Evidence or history of clinically significant diseases which can affect the patients' participation. * Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300/placebo formulation. * Participant has a history of drug or alcohol use disorder. * Participants with a positive test for cannabinoids. * Clinically significant risk of suicide or harm to self or others.

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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

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

    RECRUITING

    Chino, California, 91710, United States

  • Seaport Investigator Site

    RECRUITING

    Garden Grove, California, 92845-2506, United States

  • Seaport Investigator Site

    RECRUITING

    Glendale, California, 91206, United States

  • Seaport Investigator Site

    RECRUITING

    Redlands, California, 92373, United States

  • Seaport Investigator Site

    RECRUITING

    San Jose, California, 95124, United States

  • Seaport Investigator Site

    RECRUITING

    Cromwell, Connecticut, 06416, United States

  • Seaport Investigator Site

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Seaport Investigator Site

    RECRUITING

    Lauderhill, Florida, 33319, United States

  • Seaport Investigator Site

    RECRUITING

    Orlando, Florida, 32801, United States

  • Seaport Investigator Site

    RECRUITING

    Palm Bay, Florida, 32905, United States

  • Seaport Investigator Site

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Seaport Investigator Site

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Seaport Investigator Site

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Seaport Investigator Site

    WITHDRAWN

    Marietta, Georgia, 30060, United States

  • Seaport Investigator Site

    RECRUITING

    Boston, Massachusetts, 02116, United States

  • Seaport Investigator Site

    WITHDRAWN

    Boston, Massachusetts, 02131, United States

  • Seaport Investigator Site

    RECRUITING

    Russells Mills, Massachusetts, 02747, United States

  • Seaport Investigator Site

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Seaport Investigator Site

    RECRUITING

    Brooklyn, New York, 11235, United States

  • Seaport Investigator Site

    RECRUITING

    Cedarhurst, New York, 11516, United States

  • Seaport Investigator Site

    RECRUITING

    New York, New York, 10029, United States

  • Seaport Investigator Site

    RECRUITING

    Staten Island, New York, 10314, United States

  • Seaport Investigator Site

    RECRUITING

    Independence, Ohio, 44131, United States

  • Seaport Investigator Site

    RECRUITING

    North Canton, Ohio, 44720, United States

  • Seaport Investigator Site

    RECRUITING

    Allentown, Pennsylvania, 18104, United States

  • Seaport Investigator Site

    RECRUITING

    Dallas, Texas, 75231, United States

  • Seaport Investigator Site

    RECRUITING

    Irving, Texas, 75062, United States

  • Seaport Investigator Site

    RECRUITING

    Richardson, Texas, 75080, United States

  • Seaport Investigator Site

    RECRUITING

    Everett, Washington, 98201, United States

  • Seaport Investigator Site

    RECRUITING

    Lovech, 5500, Bulgaria

  • Seaport Investigator Site

    RECRUITING

    Plovdiv, 4004, Bulgaria

  • Seaport Investigator Site

    RECRUITING

    Sofia, 1000, Bulgaria

  • Seaport Investigator Site

    WITHDRAWN

    Sofia, 1680, Bulgaria

  • Seaport Investigator Site

    RECRUITING

    Brno, 602 00, Czechia

  • Seaport Investigator Site

    RECRUITING

    Pilsen, 301 00, Czechia

  • Seaport Investigator Site

    RECRUITING

    Prague, 100 00, Czechia

  • Seaport Investigator Site

    RECRUITING

    Prague, 110 00, Czechia

  • Seaport Investigator Site

    RECRUITING

    Prague, 160 00, Czechia

  • Seaport Investigator Site

    RECRUITING

    Prague, 186 00, Czechia

  • Seaport Investigator Site

    RECRUITING

    Berlin, Brandenburg, D-10629, Germany

  • Seaport Investigator Site

    RECRUITING

    Schwerin, Mecklenburg-Vorpommern, 19053, Germany

  • Seaport Investigator Site

    RECRUITING

    Bad Homburg, 61348, Germany

  • Seaport Investigator Site

    RECRUITING

    Chemnitz, 09111, Germany

  • Seaport Investigator Site

    RECRUITING

    Budapest, 1033, Hungary

  • Seaport Investigator Site

    RECRUITING

    Budapest, 1083, Hungary

  • Seaport Investigator Site

    RECRUITING

    Budapest, 1134, Hungary

  • Seaport Investigator Site

    RECRUITING

    Bełchatów, 97-400, Poland

  • Seaport Investigator Site

    RECRUITING

    Bialystok, 15-404, Poland

  • Seaport Investigator Site

    RECRUITING

    Bialystok, 15-464, Poland

  • Seaport Investigator Site

    RECRUITING

    Bydgoszcz, 85-080, Poland

  • Seaport Investigator Site

    RECRUITING

    Gdansk, 80-438, Poland

  • Seaport Investigator Site

    RECRUITING

    Katowice, 40-600, Poland

  • Seaport Investigator Site

    RECRUITING

    Leszno, 64-100, Poland

  • Seaport Investigator Site

    RECRUITING

    Poznan, 60-744, Poland

  • Seaport Investigator Site

    WITHDRAWN

    Torun, 87-100, Poland

  • Seaport Investigator Site

    RECRUITING

    Tuszyn, 95-080, Poland

  • Seaport Investigator Site

    RECRUITING

    Warsaw, 00-124, Poland

  • Seaport Investigator Site

    WITHDRAWN

    Wroclaw, 54-617, Poland

  • Seaport Investigator Site

    RECRUITING

    Bratislava, 82007, Slovakia

  • Seaport Investigator Site

    RECRUITING

    Rimavská Sobota, 979 01, Slovakia

  • Seaport Investigator Site

    RECRUITING

    Vranov nad Topľou, 09301, Slovakia

More trials for these conditions

Other studies related to the condition(s) this trial covers.