Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression

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

Sponsors

Lead sponsor: Sage Therapeutics

Source Sage Therapeutics
Brief 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.

Overall Status Approved for marketing
Study Type Expanded Access
Condition
Intervention

Intervention type: Drug

Intervention name: ZULRESSO (brexanolone) injection

Description: ZULRESSO

Eligibility

Criteria:

Inclusion Criteria:

1. Subject has signed an informed consent form prior to any study-specific procedures being performed

2. Subject is an ambulatory female at least 18 years of age

3. Subject agrees to adhere to the study requirements

4. Subject agrees not to be the primary caregiver of any dependents during the infusion

5. Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion

6. Subject has a current diagnosis of PPD, as assessed by the Investigator

Exclusion Criteria:

1. Subject has end stage renal disease

2. Subject has a known allergy to progesterone or allopregnanolone

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Verification Date

June 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Condition Browse
Source: ClinicalTrials.gov