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RECRUITING
NCT07822321
PHASE3

Brexanolone Lifting Outcomes Of Moms

Sponsor: Lipocine Inc.

View on ClinicalTrials.gov

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

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

Key Details

Gender

FEMALE

Age Range

15 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-09

Completion Date

2027-09

Last Updated

2026-09-16

Healthy Volunteers

No

Interventions

DRUG

LPCN 1154A

Oral LPCN 1154A tablets for 48 hours

DRUG

Placebo

Oral Placebo Tablets for 48 hours

Locations (16)

Lipocine Investigational Site

Tucson, Arizona, United States

Lipocine Investigational Site

Canoga Park, California, United States

Lipocine Investigational Site

Walnut Creek, California, United States

Lipocine Investigational Site

Aurora, Colorado, United States

Lipocine Investigational Site

Decatur, Georgia, United States

Lipocine Investigational Site

Idaho Falls, Idaho, United States

Lipocine Investigational Site

Chicago, Illinois, United States

Lipocine Investigational Site

New Orleans, Louisiana, United States

Lipocine Investigational Site

Las Vegas, Nevada, United States

Lipocine Investigational Site

Princeton, New Jersey, United States

Lipocine Investigational Site

Manhattan, New York, United States

Lipocine Investigational Site

Chapel Hill, North Carolina, United States

Lipocine Investigational Site

Plano, Texas, United States

Lipocine Investigational Site

Richardson, Texas, United States

Lipocine Investigational Site

Clinton, Utah, United States

Lipocine Investigational Site

Orem, Utah, United States