Brexanolone Lifting Outcomes Of Moms

Summary

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

Eligibility

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

Conditions7

Interventions1

Locations16 sites

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