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
Lipocine Inc.
120 participants
Sep 1, 2026
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria4
- 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
Exclusion Criteria4
- 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
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Interventions
Oral LPCN 1154A tablets for 48 hours
Oral Placebo Tablets for 48 hours
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07822321