Brexanolone Lifting Outcomes Of Moms
Lipocine Inc. · NCT07822321
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 15–45 · Women only
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 120
- US sites recruiting
- 16
- Study start
- September 2026
- Record last updated
- September 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
Being studied: LPCN 1154A; Placebo
Conditions: Depression, Postpartum; Postpartum Depression (PPD); Post-partum Depression; Postnatal Depression; Post-Natal Depression; Peripartum Depression
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Lipocine Investigational Site
Tucson, AZ 85715
Lipocine Investigational Site
Canoga Park, CA 91304
Lipocine Investigational Site
Walnut Creek, CA 94596
Lipocine Investigational Site
Aurora, CO 80045
Lipocine Investigational Site
Decatur, GA 30030
Lipocine Investigational Site
Idaho Falls, ID 83402
Lipocine Investigational Site
Chicago, IL 60641
Lipocine Investigational Site
New Orleans, LA 70115
Lipocine Investigational Site
Las Vegas, NV 89119
Lipocine Investigational Site
Princeton, NJ 08540
Lipocine Investigational Site
Manhattan, NY 10036
Lipocine Investigational Site
Chapel Hill, NC 27514
Lipocine Investigational Site
Plano, TX 75093
Lipocine Investigational Site
Richardson, TX 75080
Lipocine Investigational Site
Clinton, UT 84105
Lipocine Investigational Site
Orem, UT 84058
Study contacts (from the official record)
- Vice President of Clinical Development · 801-519-4363 · siteinquiry@lipocine.com
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