Brexanolone Lifting Outcomes Of Moms
Purpose
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
Conditions
- Depression, Postpartum
- Postpartum Depression (PPD)
- Post-partum Depression
- Postnatal Depression
- Post-Natal Depression
- Peripartum Depression
Eligibility
- Eligible Ages
- Between 15 Years and 45 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
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 Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental LPCN 1154A Tablets |
LPCN 1154A Tablets |
|
|
Placebo Comparator Placebo Tablets |
Placebo Tablets |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Lipocine Inc.
