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
Seaport Therapeutics
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugSPT-300
A prodrug of allopregnanolone, a small molecule drug
- DrugPlacebo
Placebo for SPT-300
Locations (45)
- Seaport Investigator SiteChino, California
- Seaport Investigator SiteGarden Grove, California
- Seaport Investigator SiteGlendale, California
- Seaport Investigator SiteCromwell, Connecticut
- Seaport Investigator SiteWest Palm Beach, Florida
- Seaport Investigator SiteAtlanta, Georgia