SPT-300 (GlyphAllo) for adults with major depressive disorder, with or without anxious distress

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, parallel-group, double-blind, placebo-controlled monotherapy trial comparing SPT-300 (GlyphAllo) to placebo in adults with major depressive disorder. Eligible participants are 18–65 years old with a current depressive episode lasting between 4 weeks and 18 months, and may include those with certain comorbid anxiety disorders if MDD is the primary diagnosis. Participants receive only the study drug or placebo while investigators monitor symptoms, safety, and tolerability over the treatment period. The trial is sponsored by Seaport Therapeutics with operational support from Premier Research and is conducted at Seaport Investigator sites in Southern California.

Why it matters

Who can join: the full rules

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.

Where it's running

• Seaport Investigator Site
  Chino, California, United States Recruiting
• Seaport Investigator Site
  Garden Grove, California, United States Recruiting
• Seaport Investigator Site
  Glendale, California, United States Recruiting
• Seaport Investigator Site
  Redlands, California, United States Recruiting
• Seaport Investigator Site
  San Jose, California, United States Recruiting
• Seaport Investigator Site
  Cromwell, Connecticut, United States Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: David Walling, Ph.D. — Collaborative Neuroscience Research - Garden Grove
• Study coordinator: Clinical trial information desk
• Email: clinicaltrials@seaporttx.com
• Phone: 617-807-4062

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.