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RECRUITING Phase 3 ClinicalTrials.gov

Brexanolone Lifting Outcomes Of Moms

Sponsor: Lipocine Inc. • ClinicalTrials.gov ID: NCT07822321

Registry updated: 2026-09-16
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Description

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

Interventions

  • LPCN 1154A (Drug)
    Oral LPCN 1154A tablets for 48 hours
  • Placebo (Drug)
    Oral Placebo Tablets for 48 hours

Eligibility criteria

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

Conditions

Depression, Postpartum Postpartum Depression (PPD) Post-partum Depression Postnatal Depression Post-Natal Depression Peripartum Depression

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record