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NCT Number: NCT07822321

Brexanolone Lifting Outcomes Of Moms

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

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Key information

Conditions

Depression, Postpartum Behavior Behavioral Symptoms Depression Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Peripartum Depression Post-Natal Depression Post-partum 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

Lipocine Investigational Site, Tucson, Arizona, 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 second trimester and no later than the first 4 weeks following delivery
  • Are < 18 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 associated with the current depressive episode
  • Have a history of seizure within six 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 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.

Secondary outcomes

  1. Change from baseline in HAM-D17 total score

    Time frame: Baseline to Hour 12 and Day 30

    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.

  2. Change from baseline Clinical Global Impression of Severity (CGI-S) scale positive response

    Time frame: Baseline to Hour 12, Hour 60 and Day 30

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Vice President of Clinical Development

CONTACT

[email protected]

801-519-4363 ext. 2116

Sponsors and collaborators

Lead sponsor

Lipocine Inc.

Industry

Registry information

Official study title

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

Acronym: BLOOM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 16, 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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