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Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression

Postpartum Depression Clinical Trial

Official title:
Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression

Clinical Trial Summary

This is an expanded access program intended to provide access to ZULRESSO™ (brexanolone) injection for the treatment of a limited number of eligible women with postpartum depression during the period prior to commercial availability. Requests for access must be made by a healthcare provider for a specific patient based on a determination with patient that the benefits of treatment outweigh the risks and an assessment of eligibility based on program criteria. Sites with eligible patients must apply and meet requirements for participation in the expanded access program.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03924492
Study type Expanded Access
Source Sage Therapeutics
Contact
Status Approved for marketing
Phase
View Details
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