Postpartum DepressionNCT03924492
Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression
A study testing ZULRESSO (brexanolone) injection in people with Postpartum Depression, run by Supernus Pharmaceuticals, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- ZULRESSO (brexanolone) injection
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subject has end stage renal disease
- Subject has a known allergy to progesterone or allopregnanolone
About this study
Official title: Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression
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.
- Conditions
- Postpartum Depression
- Being tested
- ZULRESSO (brexanolone) injection
- Keywords
- Expanded Access
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZULRESSO (brexanolone) injectionDrug
Also called Brexanolone, SAGE-547
ZULRESSO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924492
- Sponsor's protocol ID
- 547-PPD-401
- Status last verified
- Jun 2019
- First submitted
- 18 Apr 2019
- Last updated
- 15 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression
- ClinicalTrials.gov ID
- NCT03924492
- Acronym / sponsor ID
- 547-PPD-401
- Conditions
- Postpartum Depression
- Keywords
- Expanded Access
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Subject has end stage renal disease
- Subject has a known allergy to progesterone or allopregnanolone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZULRESSO (brexanolone) injectionAlso: Brexanolone, SAGE-547ZULRESSO | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ZULRESSO (brexanolone) injection in people with Postpartum Depression, run by Supernus Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.