Brexanolone Lifting Outcomes Of Moms

NCT ID
NCT07822321
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Phase 3
Sponsor
Lipocine Inc.

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 120 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

16 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Arizona, United States: 1
  • California, United States: 2
  • Colorado, United States: 1
  • Georgia, United States: 1
  • Idaho, United States: 1
  • Illinois, United States: 1
  • Louisiana, United States: 1
  • Nevada, United States: 1
  • New Jersey, United States: 1
  • New York, United States: 1
  • North Carolina, United States: 1
  • Texas, United States: 2
  • Utah, United States: 2

Sample of listed locations

  • Lipocine Investigational Site — Tucson, Arizona, 85715, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Canoga Park, California, 91304, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Walnut Creek, California, 94596, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Aurora, Colorado, 80045, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Decatur, Georgia, 30030, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Idaho Falls, Idaho, 83402, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Chicago, Illinois, 60641, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — New Orleans, Louisiana, 70115, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Las Vegas, Nevada, 89119, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Princeton, New Jersey, 08540, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Manhattan, New York, 10036, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Chapel Hill, North Carolina, 27514, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Plano, Texas, 75093, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Richardson, Texas, 75080, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Clinton, Utah, 84105, United States — Site recruitment status not specified in the registry data
  • Lipocine Investigational Site — Orem, Utah, 84058, United States — Site recruitment status not specified in the registry data

Study details

Start date
September 1, 2026
Primary completion date
August 1, 2027
First posted
September 16, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07822321
Registry last updated
September 16, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07822321 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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