A Phase 3 interventional study of LPCN 1154A and Placebo in Depression, Postpartum, Depression, Post-Partum and Postpartum Depression (PPD), sponsored by Lipocine Inc.. Completed at 18 sites in United States. Open to female participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-02-24.
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 enrollment of 90 is below 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
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 interests, psychomotor retardation, psychomotor agitation, anxiety (psychic and somatic), gastrointestinal symptoms, general somatic symptoms, sexual interest, 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
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
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Jan 2026, 7 months.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Brexanolone
Lipocine Inc.