CompletedPhase 3

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

United States90 participantsStarted 2025-06-16

Plain-language 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

Who can participate

Age range15 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * 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 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 within 1 year * Have a history of seizure within 6 months of Screening

What they're measuring

Change from baseline in HAM-D17 total score compared to placebo

Timeframe: Baseline to Hour 60

Trial details

NCT IDNCT06979544

SponsorLipocine Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-16

View on ClinicalTrials.gov More Depression, Postpartum trials