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

NCT06979544 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: LPCN 1154-24-002a
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 18

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
• If LPCN 1154A reduces anxiety symptoms in subjects with severe PPD

Conditions

Depression, Post-Partum; Postpartum Depression (PPD); Postnatal Depression; Peripartum Depression

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 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.

  Baseline to Hour 60

Secondary Outcomes (7)

• Incidence, severity, and causality of AEs and SAEs

  upto Day 30

• Change from baseline in HAM-D17 total score

  Baseline at Hours 12, and 36, Day 7 and Day 30

• HAM-D17 response

  Baseline to Hours 12, and 36, 60, Day 7 and Day 30

• HAM-D17 remission

  Hours 12, and 36, 60, Day 7 and Day 30

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

  Hours 12, and 36, 60, Day 7 and Day 30

Study Arms (2)

LPCN 1154A Tablets

EXPERIMENTAL

LPCN 1154A

Drug: LPCN 1154A

Placebo Tablets

PLACEBO COMPARATOR

Placebo Tablets

Drug: Placebo

Interventions

Placebo DRUG

Oral Placebo Tablets for 48 hours

Placebo Tablets

LPCN 1154A DRUG

Oral LPCN 1154A tablets for 48 hours

Also known as: Brexanolone

LPCN 1154A 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 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

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 within 1 year
• Have a history of seizure within 6 months of Screening

Sponsors & Collaborators

• Lipocine Inc.: lead

Study Sites (18)

Advanced Research Center

Anahiem, California, 92805, United States

Location

Alliance Research Institute

Canoga Park, California, 91304, United States

Location

MedOne Clinical Research, LLC

Miami, Florida, 33145, United States

Location

D&H National Research Centers

Miami, Florida, 33155, United States

Location

Meridian International Research

Miami Gardens, Florida, 33014, United States

Location

Atlanta Behavioral Research

Atlanta, Georgia, 30338, United States

Location

CenExel Research Center

Decatur, Georgia, 30030, United States

Location

CenExel Research Center

Savannah, Georgia, 31405, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Cypress Medical Research Center, LLC

Kansas City, Kansas, 67226, United States

Location

Best Clinical Trials

New Orleans, Louisiana, 70115, United States

Location

Oasis Clinical Research

Las Vegas, Nevada, 89121, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Gadolin Research

Beaumont, Texas, 77702, United States

Location

New Dawn Wellness and Medical Center

Houston, Texas, 77082, United States

Location

Maximos OB/GYN

League City, Texas, 77573, United States

Location

Populace Research

Provo, Utah, 84604, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

brexanolone

Condition Hierarchy (Ancestors)

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

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: May 13, 2025
• First Posted: May 20, 2025
• Study Start: June 16, 2025
• Primary Completion: January 16, 2026
• Study Completion: February 17, 2026
• Last Updated: February 24, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)