Postpartum DepressionPhase 4NCT05059600
A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting
A Phase 4 study testing ZULRESSO® in people with Postpartum Depression, run by Supernus Pharmaceuticals, Inc. at 6 sites in United States.
Trial summary
The primary purpose of this study was to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting. 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®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 6 sitesUnited States
- Study dates
- 8 Oct 2021to 14 Jul 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory female ≥18 years of age.
- Participant has a current diagnosis of postpartum depression (PPD), as confirmed by the investigator.
- Participant agrees not to be the primary caregiver of any dependents during the infusion and must be accompanied by another adult (other than the home healthcare provider) during interactions with their child(ren).
- Participant has no history of sleep apnea or any clinically significant respiratory conditions.
- Participant agrees to refrain from the use of central nervous system depressants, such as opioids, benzodiazepines, sleep aids and from drinking alcohol during the infusion.
- Participant is suitable for administration of ZULRESSO® in a home setting, as per the judgement of the investigator.
Show all 15Show fewer
- Participant's home is suitable and has necessary provisions for administration of ZULRESSO® and meets the following criteria:
- safe environment for the home infusion provider staff.
- access to a working telephone.
- electricity and grounded electrical outlets.
- running water.
- access to back-up emergency services (911 service or ambulance availability).
- sanitary environment.
- Participant agrees to stay at home until the end-of-study visit has been completed, except for a medical emergency.
- Participant must have a negative pregnancy test at screening and on Day 1 prior to the start of the ZULRESSO® infusion.
Who cannot join
- Participant has end stage renal failure.
- Participant has known allergy to progesterone or allopregnanolone or any excipients in the brexanolone injection.
- Participant is currently at risk of suicide, as judged by the investigator, or has attempted suicide associated with the current episode of PPD.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Sage Investigational Site
Culver City, California, 90230
Virtual Site (recruiting nationwide)
Culver City, California, 90230
Sage Investigational Site
League City, Texas, 77573
Sage Investigational Site
Miramar, Florida, 33029
Sage Investigational Site
New York, New York, 10036
Sage Investigational Site
Pompano Beach, Florida, 33060
About this study
Official title: Assessment of Safe-use Conditions for Administration of ZULRESSO in a Home Setting
The primary purpose of this study was to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting.
- Conditions
- Postpartum Depression
- Being tested
- ZULRESSO®
- 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®Drug
Also called Allopregnanolone, Brexanolone, SAGE-547
Intravenous infusion of ZULRESSO®.
| Study group | Role | What they receive |
|---|---|---|
| ZULRESSO® | Experimental | Participants received a 60-hour single continuous intravenous (IV) infusion of ZULRESSO®, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a dose taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study. Receives: Drug: ZULRESSO® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to the nearest single decimal.
Measured: Up to Day 3
Secondary outcomes (4)
Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO®
Nonadherence was defined by failure of any of following:
- Home infusion provider to train all pharmacy and home healthcare providers (HHPs) in dispensing/administration of ZULRESSO® on risk of excessive sedation/loss of consciousness
- HHPs to counsel participants on risk of excessive sedation/loss of consciousness
- Deliver ZULRESSO® per protocol
- Provide preprogrammed peristaltic pump
- HHP:assess excessive sedation every 2 hours in planned nonsleep periods, change infusion bag per protocol, at least one HHP available in participant's home for the duration of infusion
- Fall protocol in place
- Monitor participants with pulse oximeter
- Stop infusion when participant is primary caregiver of dependents and/or identification of excessive sedation/loss of consciousness/hypoxic episode
- Caution participants post-infusion against engaging in hazardous activities requiring mental alertness
- Complete AE of special interest/Serious AE form
- Infusion resumed after hypoxia episode
Measured: Up to Day 3
Number of Use-Related Issues Related to the Home Administration of ZULRESSO®
Home healthcare provider (HHP) staff completed checklists at end of each day and/or shift to document any use-related issues throughout duration of infusion. Any use-related issues determined to be critical in nature were followed up immediately and were reported adequately. Use-related issues were categorized as Critical Use Error (UE): HHP failed to complete a task or made uncorrected use error during task that could have resulted in harm, compromised medical care, incidence of nonadherence with safe use conditions for administration of ZULRESSO, or incidence of use-related issues related to home administration of ZULRESSO; Use Difficulty (UD): HHP successfully completed a task but did so while experiencing issues/operational difficulties; Close Call (CC): HHP committed error that could have led to a task failure, but self-corrected and completed task successfully. Multiple occurrences of issue throughout a single infusion was included only once in total.
Measured: Up to Day 3
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to nearest single decimal.
Measured: Up to Day 3
Percentage of Participants With Medication Error
Medication error was any preventable event that may cause or lead to inappropriate medication use or participant harm while the medication was in the control of the healthcare professional, participant, or consumer. Percentages are rounded off to the nearest single decimal.
Measured: At screening and during the study (Up to Day 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start8 Oct 2021
- Primary completion14 Jul 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059600
- Sponsor's protocol ID
- 547-PPD-404
- Status last verified
- Jun 2023
- First submitted
- 17 Sep 2021
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov
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
- Assessment of Safe-use Conditions for Administration of ZULRESSO in a Home Setting
- ClinicalTrials.gov ID
- NCT05059600
- Acronym / sponsor ID
- 547-PPD-404
- Conditions
- Postpartum Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Posted 19 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study was to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZULRESSO® | Experimental | Drug: ZULRESSO®Participants received a 60-hour single continuous intravenous (IV) infusion of ZULRESSO®, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a dose taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Ambulatory female ≥18 years of age.
- Participant has a current diagnosis of postpartum depression (PPD), as confirmed by the investigator.
- Participant agrees not to be the primary caregiver of any dependents during the infusion and must be accompanied by another adult (other than the home healthcare provider) during interactions with their child(ren).
- Participant has no history of sleep apnea or any clinically significant respiratory conditions.
- Participant agrees to refrain from the use of central nervous system depressants, such as opioids, benzodiazepines, sleep aids and from drinking alcohol during the infusion.
Key exclusion criteria (3 listed)
- Participant has end stage renal failure.
- Participant has known allergy to progesterone or allopregnanolone or any excipients in the brexanolone injection.
- Participant is currently at risk of suicide, as judged by the investigator, or has attempted suicide associated with the current episode of PPD.
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®Also: Allopregnanolone, Brexanolone, SAGE-547Intravenous infusion of ZULRESSO®. | Drug | ZULRESSO® |
Primary outcome
Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation
Time frame: Up to Day 3
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to the nearest single decimal.
4 secondary outcomes
Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO®
Time frame: Up to Day 3
Number of Use-Related Issues Related to the Home Administration of ZULRESSO®
Time frame: Up to Day 3
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 3
Percentage of Participants With Medication Error
Time frame: At screening and during the study (Up to Day 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data sharing will be consistent with the results submission policy of ClinicalTrials.gov
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ZULRESSO® in people with Postpartum Depression, run by Supernus Pharmaceuticals, Inc. at 6 sites in United States.
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 15 inclusion and 3 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: finished, 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.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation (time frame: Up to Day 3). It is what the study was designed to measure, not a finding.
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.