A Study to Assess the Safety and Efficacy of Oral LPCN 1154A in Women With Severe PPD
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 - If LPCN 1154A reduces anxiety symptoms in subjects with severe PPD
Conditions
- Depression, Postpartum
- Depression, Post-Partum
- Postpartum Depression (PPD)
- Post-Natal Depression
- Peripartum Depression
- Postnatal 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 third trimester and later than the first 4 week following delivery - Are < 12 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 within 1 year - Have a history of seizure within 6 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 |
|
|
Placebo Comparator Placebo Tablets |
Placebo Tablets |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Lipocine Inc.
