A Phase 3 interventional study of LPCN 1154A and Placebo in Depression, Postpartum, Postpartum Depression (PPD) and Post-partum Depression, sponsored by Lipocine Inc.. Recruiting at 16 sites in United States. Open to female participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Lipocine Inc. · Phase 3, Interventional, and Treatment
The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD). The trial aims to determine:
569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.
This study's planned enrollment of 120 is above the median of 104 across 454 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Lipocine Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
LPCN 1154A Tablets
Drug: LPCN 1154A
Placebo Tablets
Drug: Placebo
Oral LPCN 1154A tablets for 48 hours
Also known as: Brexanolone
Oral Placebo Tablets for 48 hours
Change from baseline in HAM-D17 total score compared to placebo
The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and activities, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Time frame: Baseline to Hour 60
Change from baseline in HAM-D17 total score
The Seventeen-Item Hamilton Rating Scale for Depression (HAM-D17) contains 17 individual ratings related to the following symptoms: depressed mood, feelings of guilt, suicide, insomnia (initial, middle, and late), work and activities, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, genital symptoms, hypochondriasis, insight, and weight loss. The total score ranges from 0 to 52, with higher scores indicating more severe depression.
Time frame: Baseline to Hour 12 and Day 30
Change from baseline Clinical Global Impression of Severity (CGI-S) scale positive response
The CGI-S scale is a 7-point scale that requires the Investigator to assess the severity of a patient's illness. Scores range from 1 -normal, not at all ill to 7 - among the most extremely ill patients
Time frame: Baseline to Hour 12, Hour 60 and Day 30
Plan to share: No
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Studies of the drug tested here: Brexanolone
Lipocine Inc.