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Completed

NCT Number: NCT05059600

A Study To Assess The 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.

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Key information

Conditions

Postpartum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sage Investigational Site, Culver City, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

ZULRESSO®

Drug

Intravenous infusion of ZULRESSO®.

Other names: Allopregnanolone, Brexanolone, SAGE-547

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO®

    Time frame: 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 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

  2. Number of Use-Related Issues Related to the Home Administration of ZULRESSO®

    Time frame: 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 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.

  3. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: 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.

  4. Percentage of Participants With Medication Error

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Supernus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Assessment of Safe-use Conditions for Administration of ZULRESSO in a Home Setting

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 28, 2021
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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