Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing SPT-300 for Major Depressive Disorder (MDD)

This is a randomly assigned, parallel-group, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, this drug alone study to measure the how well it works, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (major depression), with or without anxious distress.

Official registry: https://clinicaltrials.gov/study/NCT07065240 · Seaport Therapeutics · enrollment listed as 360

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are SPT-300, or Placebo. The registry lists allocation as randomized. This is a randomly assigned, parallel-group, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, this drug alone study to measure the how well it works, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (major depression), with or without anxious distress.

They plan to enroll about 360 people at 54 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults With Major Depressive Disorder (MDD), With or Without Anxious Distress

Interventions: SPT-300, Placebo

Primary outcome (registry wording): Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening
  • Body mass index (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

Public study contact (from the registry)

Clinical trial information desk

617-807-4062

clinicaltrials@seaporttx.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

54 listed

+ 26 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07065240 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07065240?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07065240?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary