NCT05059600

A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting

Completed Phase 4 Results posted Last updated 15 September 2025

What this trial tests

Phase 4 trial testing ZULRESSO® in Postpartum Depression in 52 participants. Completed in 14 July 2022.

Timeline

8 October 2021

Primary endpoint
14 July 2022

14 July 2022

Quick facts

Lead sponsor	Supernus Pharmaceuticals, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	8 October 2021
Primary completion	14 July 2022
Estimated completion	14 July 2022
Sites	6 locations across United States

Drugs / interventions tested

• ZULRESSO® — full drug profile →

Conditions studied

• Postpartum Depression — all drugs for Postpartum Depression →

Sponsor

Supernus Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, female only, with Postpartum Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation Primary · 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.

Group	Value	95% CI
ZULRESSO®	7.1

Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO® Secondary · Up to Day 3

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 p

Group	Value	95% CI
ZULRESSO®	76.19

Number of Use-Related Issues Related to the Home Administration of ZULRESSO® Secondary · Up to Day 3

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

Critical Use Errors (UE)

Group	Value	95% CI
ZULRESSO®	13

Use Difficulties (UD)

Group	Value	95% CI
ZULRESSO®	62

Close Calls (CC)

Group	Value	95% CI
ZULRESSO®	0

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Secondary · Up to Day 3

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.

Group	Value	95% CI
ZULRESSO®	42.9

Percentage of Participants With Medication Error Secondary · At screening and during the study (Up to Day 3)

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.

At Screening

Group	Value	95% CI
ZULRESSO®	28.6

During the Study (Up to Day 3)

Group	Value	95% CI
ZULRESSO®	54.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Day 3. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ZULRESSO®

Serious: 0/42 (0%)

Deaths: 0/42

Other adverse events (4 terms — click to expand)

Reaction	System	ZULRESSO®
Fatigue	General disorders	—
Headache	Nervous system disorders	—
Infusion site pain	General disorders	—
Somnolence	Nervous system disorders	—

Data from ClinicalTrials.gov NCT05059600 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Trends of Decentralized Clinical Trials Using Digital Technology for Decentralization
   Sato T, Mizumoto S, Ota M, Shikano M. · · 2022 · DOI 10.2139/ssrn.4243284