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NCT03924492 Clinical Trial

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 Details — Status: Approved for marketing

Administrative data
NCT number NCT03924492
Other study ID # 547-PPD-401
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date June 2019
Source Sage Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

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.

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ZULRESSO (brexanolone) injection
ZULRESSO

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sage Therapeutics
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