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Completed

NCT Number: NCT06979544

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

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:

* If LPCN 1154A reduces depressive symptoms in subjects with severe PPD * How well LPCN 1154A is tolerated and what side effects it may cause * If LPCN 1154A reduces anxiety symptoms in subjects with severe PPD

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Key information

Conditions

Depression, Postpartum Depression, Post-Partum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Peripartum Depression Post-Natal Depression Postnatal Depression Postpartum Depression (PPD) Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Advanced Research Center, Anahiem, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Are female between 15 and 45 years of age, inclusive;
  • Have had a depressive episode that began no earlier than third trimester and later than the first 4 week following delivery
  • Are < 12 months postpartum at Screening
  • Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression

Key Exclusion Criteria:

  • Have a history of bipolar disorder, schizophrenia or schizoaffective disorder
  • Are currently experiencing active psychosis per Investigator assessment
  • Have a history of suicidal behavior within 1 year
  • Have a history of seizure within 6 months of Screening

Treatment and study plan

LPCN 1154A

Drug

Oral LPCN 1154A tablets for 48 hours

Other names: Brexanolone

Placebo

Drug

Oral Placebo Tablets for 48 hours

Primary outcomes

  1. Change from baseline in HAM-D17 total score compared to placebo

    Time frame: Baseline to Hour 60

    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.

Secondary outcomes

  1. Incidence, severity, and causality of AEs and SAEs

    Time frame: upto Day 30

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

  2. Change from baseline in HAM-D17 total score

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

    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.

  3. HAM-D17 response

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

    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.

  4. HAM-D17 remission

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

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

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

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

    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.

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

    Time frame: Baseline to Hour 60 and Day 30

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

Lipocine Inc.

Industry

Registry information

Official study title

A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Saftey and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 20, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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