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NCT07822321PHASE3Recruiting

Brexanolone Lifting Outcomes Of Moms

Lipocine Inc.

Start Date

9/1/2026

Completion Date

9/1/2027

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 Criteria

Age Range: 15 years to 45 years

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

Interventions

DRUG

LPCN 1154A

DRUG

Placebo

Interested in This Trial?

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Conditions

Depression, PostpartumPostpartum Depression (PPD)Post-partum DepressionPostnatal DepressionPost-Natal DepressionPeripartum Depression

Locations

Lipocine Investigational Site

Tucson, Arizona 85715

United States

Lipocine Investigational Site

Canoga Park, California 91304

United States

Lipocine Investigational Site

Walnut Creek, California 94596

United States

Lipocine Investigational Site

Aurora, Colorado 80045

United States

Lipocine Investigational Site

Decatur, Georgia 30030

United States

Lipocine Investigational Site

Idaho Falls, Idaho 83402

United States

Lipocine Investigational Site

Chicago, Illinois 60641

United States

Lipocine Investigational Site

New Orleans, Louisiana 70115

United States

Lipocine Investigational Site

Las Vegas, Nevada 89119

United States

Lipocine Investigational Site

Princeton, New Jersey 08540

United States

Lipocine Investigational Site

Manhattan, New York 10036

United States

Lipocine Investigational Site

Chapel Hill, North Carolina 27514

United States

Lipocine Investigational Site

Plano, Texas 75093

United States

Lipocine Investigational Site

Richardson, Texas 75080

United States

Lipocine Investigational Site

Clinton, Utah 84105

United States

Lipocine Investigational Site

Orem, Utah 84058

United States