Overview

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

Eligibility

Key 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

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 within 1 year
• Have a history of seizure within 6 months of Screening