Back to search results

SPT-300 (GlyphAllo) for Major Depressive Disorder

This study is testing a drug called SPT-300 (GlyphAllo) for people with major depressive disorder (MDD), including those who also experience anxious distress. SPT-300 is a small molecule drug. Researchers want to see how well SPT-300 works and if it's safe compared to a placebo (an inactive substance). The study aims to enroll 360 participants between 18 and 65 years old who have been diagnosed with MDD. Success will be measured by changes in depression symptoms using a standard rating scale (Hamilton Depression Rating Scale-17) after 42 days. The current recruitment status is unclear.

Study design
This is a randomized, double-blind study where participants will receive either SPT-300 or a placebo. It plans to include 360 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in depression symptoms up to Day 42.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07065240

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)

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Seaport Therapeutics
~360 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:SPT-300Placebo

At a glance

Recruiting sites
57 of 62 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score
Measured over Baseline (Day 0) to Day 42

Conditions

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

Explore related trials

Unipolar Depression

Where it's being run

62 sites across 19 states
Poland12
Czechia6
California5
Florida5
New York4
Bulgaria4
Georgia3
Massachusetts3

Study leadership

  • David Walling, Ph.D. · PRINCIPAL_INVESTIGATOR · Collaborative Neuroscience Research - Garden Grove

Who to contact

Clinical trial information desk
[email protected]
617-807-4062
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

History of, or current presentation consistent with:
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.

What this trial measures

  • Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total ScoreBaseline (Day 0) to Day 42

    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), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. HAM-D Total Scores range from 0 to 52, with higher scores indicating more severe depression.