A Phase 4 interventional study of ZULRESSO® in Postpartum Depression, sponsored by Supernus Pharmaceuticals, Inc.. Completed at 6 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Supernus Pharmaceuticals, Inc. · Phase 4, Interventional, and Treatment
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.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's enrollment of 52 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Supernus Pharmaceuticals, Inc. is the lead sponsor of 61 studies on the registry; 6 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 25 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participant's home is suitable and has necessary provisions for administration of ZULRESSO® and meets the following criteria:
Exclusion Criteria:
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.
Drug: ZULRESSO®
Intravenous infusion of ZULRESSO®.
Also known as: Allopregnanolone, Brexanolone, SAGE-547
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.
Time frame: Up to Day 3
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At screening and during the study (Up to Day 3)
Participants were enrolled at 5 active clinical sites in the United States from 08 October 2021 to 14 July 2022.
| Milestone | ZULRESSO® |
|---|---|
| Started | 52 |
| Treated | 42 |
| Completed | 42 |
| Not completed | 10 |
| Withdrew: Enrolled but not treated | 10 |
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.
| percentage of participants | ZULRESSO® |
|---|---|
| Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation | 7.1 |
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
| percentage of participants | ZULRESSO® |
|---|---|
| Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO® | 76.19 |
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.
| Issues | ZULRESSO® |
|---|---|
| Critical Use Errors (UE) | 13 |
| Use Difficulties (UD) | 62 |
| Close Calls (CC) | 0 |
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.
| percentage of participants | ZULRESSO® |
|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | 42.9 |
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.
| percentage of participants | ZULRESSO® |
|---|---|
| At Screening | 28.6 |
| During the Study (Up to Day 3) | 54.8 |
Collected over Up to Day 3. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ZULRESSO® | 0/42 (0%) | 0/42 (0%) | 15/42 (35.7%) |
| Event | ZULRESSO® |
|---|---|
| FatigueGeneral disorders | 5/42 |
| HeadacheNervous system disorders | 4/42 |
| Infusion site painGeneral disorders | 3/42 |
| SomnolenceNervous system disorders | 3/42 |
Safety Set included all participants who were administered ZULRESSO®.
| Age, Continuous(years) | ZULRESSO® |
|---|---|
| Mean | 31.9 ± 5.76 |
| Sex: Female, Male(Participants) | ZULRESSO® |
|---|---|
| Female | 42 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | ZULRESSO® |
|---|---|
| Hispanic or Latino | 18 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | ZULRESSO® |
|---|---|
| White | 33 |
| Black or African American | 6 |
| Asian | 1 |
| American Indian or Alaska Native | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Other | 1 |
| Not Specified | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Data sharing will be consistent with the results submission policy of ClinicalTrials.gov
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Supernus Pharmaceuticals, Inc.