A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD

Incidence, severity, and causality of AEs and SAEs

Adverse events (AEs) and Serious Adverse Events (SAEs)

Time frame: upto Day 30

Change from baseline in HAM-D17 total score

The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) evaluates mood, suicide, work and interests, retardation, agitation, gastrointestinal symptoms, somatic symptoms, hypochondriasis, body weight and insight The total score ranges from 0 to 52, with higher scores indicating more severe depression.

Time frame: Baseline at Hours 12, and 36, Day 7 and Day 30

HAM-D17 response

Defined as having a 50% or greater reduction from baseline in HAM-D17 total score. The total score ranges from 0 to 52, with higher scores indicating more severe depression.

Time frame: Baseline to Hours 12, and 36, 60, Day 7 and Day 30

HAM-D17 remission

Defined as having a HAM-D17 total score ≤7. The total score ranges from 0 to 52, with higher scores indicating more severe depression.

Time frame: Hours 12, and 36, 60, Day 7 and Day 30

Patient Global Impression - Change (PGI-C) scale positive response

The PGI-C scale is a 7-point scale that ranges from "1-very much better" to "7-very much worse" that allows participants to self- report their perception of improvement or decline of overall symptoms since starting treatment.

Time frame: Hours 12, and 36, 60, Day 7 and Day 30

Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score

The MADRS is a 10-item assessment that evaluates mood/thoughts, sleep, appetite, tension, concentration The total score ranges from 0 to 60, with higher scores indicating more severe depression.

Time frame: Baseline to Hour 60 and Day 30

Change from baseline in Hamilton Anxiety Rating Scale (HAM-A) total score

The HAM-A is a 14-item assessment that evaluates mood, tension, fear, memory/concentration, sleep, and physical symptoms affecting somatic, sensory, respiratory, cardiovascular, gastrointestinal, genitourinary, and autoimmune systems as it relates to anxiety. The total score ranges from 0 to 56, with higher scores indicating more severe anxiety.

Time frame: Baseline to Hours 12, 36, 60 Day 7 and Day 30