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Brexanolone Lifting Outcomes Of Moms

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

Who can join

Ages 15 to 45 · Women

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

About the study

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

What is being tested

• LPCN 1154A (drug)
• Placebo (drug)

Sponsor: Lipocine Inc. · Participants: 120 · Started: 2026-09

Contact the study team

• Vice President of Clinical Development · Phone: 801-519-4363

Official record on ClinicalTrials.gov — NCT07822321

Locations in the U.S.

Conditions

• Postpartum Depression
• Depression

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.