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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