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.
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.
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.
Parallel
SPT-300
DrugA prodrug of allopregnanolone, a small molecule drug
Placebo
DrugPlacebo for SPT-300
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.
Change From Baseline to Day 42 in Clinical Global Impression - Severity (CGI-S)
The CGI-S is a clinician-administered rating scale to assess the severity of the participant's illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. Scores range from 1 to 7, with higher scores indicating more severe illness.
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Seaport Therapeutics
Lead sponsor
Premier Research
Collaborator
