Back to resultsExpanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression
Primary Purpose
Postpartum Depression
Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
ZULRESSO (brexanolone) injection
Sponsored by
About this trial
This is an expanded access trial for Postpartum Depression focused on measuring Expanded Access
Eligibility Criteria
Inclusion Criteria:
- Subject has signed an informed consent form prior to any study-specific procedures being performed
- Subject is an ambulatory female at least 18 years of age
- Subject agrees to adhere to the study requirements
- Subject agrees not to be the primary caregiver of any dependents during the infusion
- Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion
- Subject has a current diagnosis of PPD, as assessed by the Investigator
Exclusion Criteria:
- Subject has end stage renal disease
- Subject has a known allergy to progesterone or allopregnanolone
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03924492
Brief Title
Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression
Official Title
Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Therapeutics
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Expanded Access
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ZULRESSO (brexanolone) injection
Other Intervention Name(s)
Brexanolone, SAGE-547
Intervention Description
ZULRESSO
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Subject has signed an informed consent form prior to any study-specific procedures being performed
Subject is an ambulatory female at least 18 years of age
Subject agrees to adhere to the study requirements
Subject agrees not to be the primary caregiver of any dependents during the infusion
Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion
Subject has a current diagnosis of PPD, as assessed by the Investigator
Exclusion Criteria:
Subject has end stage renal disease
Subject has a known allergy to progesterone or allopregnanolone
12. IPD Sharing Statement
Learn more about this trial
Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression
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