Brexanolone Lifting Outcomes Of Moms

NCT07822321 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: LPCN 1154-26-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 16

Brief Summary

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

Conditions

Postpartum Depression (PPD); Post-Natal Depression; Peripartum Depression; Depression, Postpartum; Post-partum Depression

Keywords

Postpartum Depression; PPD; Depression; LPCN 1154A; brexanolone; neuroactive steriod; GABAA

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Hour 60

Secondary Outcomes (2)

• Change from baseline in HAM-D17 total score

  Baseline to Hour 12 and Day 30

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

  Baseline to Hour 12, Hour 60 and Day 30

Study Arms (2)

LPCN 1154A Tablets

EXPERIMENTAL

LPCN 1154A Tablets

Drug: LPCN 1154A

Placebo Tablets

PLACEBO COMPARATOR

Placebo Tablets

Drug: Placebo

Interventions

LPCN 1154A DRUG

Oral LPCN 1154A tablets for 48 hours

Also known as: Brexanolone

LPCN 1154A Tablets

Placebo DRUG

Oral Placebo Tablets for 48 hours

Placebo Tablets

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lipocine Inc.: lead

Study Sites (16)

Lipocine Investigational Site

Tucson, Arizona, 85715, United States

RECRUITING

Lipocine Investigational Site

Canoga Park, California, 91304, United States

RECRUITING

Lipocine Investigational Site

Walnut Creek, California, 94596, United States

RECRUITING

Lipocine Investigational Site

Aurora, Colorado, 80045, United States

RECRUITING

Lipocine Investigational Site

Decatur, Georgia, 30030, United States

RECRUITING

Lipocine Investigational Site

Idaho Falls, Idaho, 83402, United States

RECRUITING

Lipocine Investigational Site

Chicago, Illinois, 60641, United States

RECRUITING

Lipocine Investigational Site

New Orleans, Louisiana, 70115, United States

RECRUITING

Lipocine Investigational Site

Las Vegas, Nevada, 89119, United States

RECRUITING

Lipocine Investigational Site

Princeton, New Jersey, 08540, United States

RECRUITING

Lipocine Investigational Site

Manhattan, New York, 10036, United States

RECRUITING

Lipocine Investigational Site

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Lipocine Investigational Site

Plano, Texas, 75093, United States

RECRUITING

Lipocine Investigational Site

Richardson, Texas, 75080, United States

RECRUITING

Lipocine Investigational Site

Clinton, Utah, 84105, United States

RECRUITING

Lipocine Investigational Site

Orem, Utah, 84058, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Depression

Interventions

brexanolone

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Vice President of Clinical Development

CONTACT

801-519-4363; siteinquiry@lipocine.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)