NCT07065240

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
10mo left

Started Jun 2025

Geographic Reach
6 countries

45 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Jun 2025Mar 2027

Study Start

First participant enrolled

June 19, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

July 3, 2025

Last Update Submit

March 20, 2026

Conditions

Major Depressive Disorder With Anxious DistressMajor Depressive Disorder (MDD)

Keywords

Major Depressive DisorderDepressive DisorderDepressionAnxietyMood DisordersBUOY-1 StudySPT-300LYT-300GlyphAlloGlyph Allopregnanolone

Outcome Measures

Primary Outcomes (1)

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

    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.

    Baseline (Day 0) to Day 42

Secondary Outcomes (1)

  • Change From Baseline to Day 42 in Clinical Global Impression - Severity (CGI-S)

    Baseline (Day 0) to Day 42

Study Arms (2)

SPT-300

EXPERIMENTAL

Participants will receive SPT-300 capsules once daily for 42 days

Drug: SPT-300

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo once daily for 42 days

Drug: Placebo

Interventions

SPT-300DRUG

A prodrug of allopregnanolone, a small molecule drug

Also known as: LYT-300, GlyphAllo, Glyph Allopregnanolone
SPT-300
PlaceboDRUG

Placebo for SPT-300

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • History of, or current presentation consistent with:
  • any depressive episode with psychotic or catatonic features.
  • any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode.
  • bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.
  • schizophrenia, schizoaffective, or other psychotic disorder.
  • obsessive-compulsive disorder.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

Seaport Investigator Site

Chino, California, 91710, United States

RECRUITING

Seaport Investigator Site

Garden Grove, California, 92845-2506, United States

RECRUITING

Seaport Investigator Site

Glendale, California, 91206, United States

RECRUITING

Seaport Investigator Site

Cromwell, Connecticut, 06416, United States

RECRUITING

Seaport Investigator Site

West Palm Beach, Florida, 33407, United States

RECRUITING

Seaport Investigator Site

Atlanta, Georgia, 30328, United States

RECRUITING

Seaport Investigator Site

Decatur, Georgia, 30030, United States

RECRUITING

Seaport Investigator Site

Marietta, Georgia, 30060, United States

RECRUITING

Seaport Investigator Site

Boston, Massachusetts, 02116, United States

RECRUITING

Seaport Investigator Site

Boston, Massachusetts, 02131, United States

RECRUITING

Seaport Investigator Site

St Louis, Missouri, 63141, United States

RECRUITING

Seaport Investigator Site

Brooklyn, New York, 11235, United States

RECRUITING

Seaport Investigator Site

New York, New York, 10029, United States

RECRUITING

Seaport Investigator Site

Staten Island, New York, 10314, United States

RECRUITING

Seaport Investigator Site

Independence, Ohio, 44131, United States

RECRUITING

Seaport Investigator Site

North Canton, Ohio, 44720, United States

RECRUITING

Seaport Investigator Site

Irving, Texas, 75062, United States

RECRUITING

Seaport Investigator Site

Plovdiv, 4004, Bulgaria

RECRUITING

Seaport Investigator Site

Sofia, 1000, Bulgaria

RECRUITING

Seaport Investigator Site

Sofia, 1680, Bulgaria

RECRUITING

Seaport Investigator Site

Brno, 602 00, Czechia

RECRUITING

Seaport Investigator Site

Pilsen, 301 00, Czechia

RECRUITING

Seaport Investigator Site

Prague, 100 00, Czechia

RECRUITING

Seaport Investigator Site

Prague, 110 00, Czechia

RECRUITING

Seaport Investigator Site

Prague, 160 00, Czechia

RECRUITING

Seaport Investigator Site

Prague, 186 00, Czechia

RECRUITING

Seaport Investigator Site

Berlin, Brandenburg, D-10629, Germany

RECRUITING

Seaport Investigator Site

Schwerin, Mecklenburg-Vorpommern, 19053, Germany

RECRUITING

Seaport Investigator Site

Bad Homburg, 61348, Germany

RECRUITING

Seaport Investigator Site

Chemnitz, 09111, Germany

RECRUITING

Seaport Investigator Site

Bełchatów, 97-400, Poland

RECRUITING

Seaport Investigator Site

Bialystok, 15-404, Poland

RECRUITING

Seaport Investigator Site

Bialystok, 15-464, Poland

RECRUITING

Seaport Investigator Site

Bydgoszcz, 85-080, Poland

RECRUITING

Seaport Investigator Site

Gdansk, 80-438, Poland

RECRUITING

Seaport Investigator Site

Katowice, 40-600, Poland

RECRUITING

Seaport Investigator Site

Leszno, 64-100, Poland

RECRUITING

Seaport Investigator Site

Poznan, 60-744, Poland

RECRUITING

Seaport Investigator Site

Torun, 87-100, Poland

WITHDRAWN

Seaport Investigator Site

Tuszyn, 95-080, Poland

RECRUITING

Seaport Investigator Site

Warsaw, 00-124, Poland

RECRUITING

Seaport Investigator Site

Wroclaw, 54-617, Poland

RECRUITING

Seaport Investigator Site

Bratislava, 82007, Slovakia

RECRUITING

Seaport Investigator Site

Rimavská Sobota, 979 01, Slovakia

RECRUITING

Seaport Investigator Site

Vranov nad Topľou, 09301, Slovakia

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive DisorderDepressionAnxiety DisordersMood Disorders

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • David Walling, Ph.D.

    Collaborative Neuroscience Research - Garden Grove

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical trial information desk

CONTACT

617-807-4062clinicaltrials@seaporttx.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 15, 2025

Study Start

June 19, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

US(17)BU(3)PL(12)CZ(6)SL(3)DE(4)