Brexanolone Lifting Outcomes Of Moms (BLOOM)

September 10, 2026 updated by: Lipocine Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Lipocine Investigational Site
    • California
      • Canoga Park, California, United States, 91304
        • Recruiting
        • Lipocine Investigational Site
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Lipocine Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Lipocine Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Lipocine Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83402
        • Recruiting
        • Lipocine Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60641
        • Recruiting
        • Lipocine Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Recruiting
        • Lipocine Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • Lipocine Investigational Site
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Recruiting
        • Lipocine Investigational Site
    • New York
      • Manhattan, New York, United States, 10036
        • Recruiting
        • Lipocine Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • Lipocine Investigational Site
    • Texas
      • Plano, Texas, United States, 75093
        • Recruiting
        • Lipocine Investigational Site
      • Richardson, Texas, United States, 75080
        • Recruiting
        • Lipocine Investigational Site
    • Utah
      • Clinton, Utah, United States, 84105
        • Recruiting
        • Lipocine Investigational Site
      • Orem, Utah, United States, 84058
        • Recruiting
        • Lipocine Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Tablets
Drug: Placebo
Oral Placebo Tablets for 48 hours
Experimental: LPCN 1154A Tablets
Drug: LPCN 1154A
Oral LPCN 1154A tablets for 48 hours
Other Names:
  • Brexanolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Hour 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Hour 12 and Day 30
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
Baseline to Hour 12, Hour 60 and Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lipocine Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPCN 1154-26-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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