Evaluation of Brexanolone Caprilcerbate Monotherapy in Adults with Major Depressive Disorder with or without Anxious Distress: A 6-Week Open-Label Study

The primary objective is to evaluate the safety and tolerability of oral doses of SPT-300 in adults diagnosed with major depressive disorder, with or without anxious distress. Secondary objectives include the assessment of the efficacy of SPT-300 as monotherapy regarding:

• Depressive symptoms
• Anxiety symptoms
• Illness severity
• Functioning
• Quality of life

This study involves a total of 129 participants diagnosed with Major Depressive Disorder, with or without anxious distress. The study population includes both male and female individuals, categorized within age ranges 3 and 4, and includes vulnerable populations. Participants are selected based on the completion of treatment in a previous study, specifically through the completion of visit 6 at day 42. Key inclusion requirements necessitate the ability to provide written informed consent and the capacity to adhere to the protocol. Women of childbearing potential must not be breastfeeding or planning pregnancy, and all participants must utilize effective contraception. Additionally, subjects must be willing to refrain from alcohol and drugs of abuse, including recreational or medical cannabinoids, for the duration of the trial.

This 6-week, multicenter, open-label, monotherapy, extension study is a Phase 4 trial designed to evaluate the safety and tolerability of oral brexanolone caprilcerbate in adults diagnosed with major depressive disorder, with or without anxious distress. The study is intended for participants who have completed the prior treatment phase in study SPT-300-2024-203-OUS. The primary objectives include monitoring the incidence, severity, and duration of treatment-emergent adverse events, serious adverse events, and clinically significant findings in vital signs, electrocardiograms, safety laboratory tests, and physical examination. Assessment of suicidal ideation and behavior will be conducted using the Columbia Suicide Severity Rating Scale. Secondary endpoints involve measuring changes from baseline in the Hamilton Depression Rating Scale-17, Clinical Global Impressions-Severity, Hamilton Anxiety Rating Scale, Patient Global Impression-Severity, Sheehan Disability Scale, and the Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form.

The experimental medication consists of brexanolone caprilcerbate administered in a capsule pharmaceutical form. The oral dosage is 375 mg.

The assessment of efficacy in this study involving patients with Major Depressive Disorder includes the evaluation of changes from baseline to Study Day 42. Secondary endpoints comprise measurements of the Hamilton Depression Rating Scale (HAM-D-17) total score, the Clinical Global Impression-Severity Scale (CGI-S), the Hamilton Anxiety Rating Scale, the Patient Global Impression-Severity Scale (PGI-S), the Sheehan Disability Scale, and the Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form.