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

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ZULRESSO®
Sponsored by
Sage Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ambulatory female ≥18 years of age.
  2. Participant has a current diagnosis of postpartum depression (PPD), as confirmed by the investigator.
  3. 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).
  4. Participant has no history of sleep apnea or any clinically significant respiratory conditions.
  5. 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.
  6. Participant is suitable for administration of ZULRESSO® in a home setting, as per the judgement of the investigator.

  7. 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.
  8. Participant agrees to stay at home until the end-of-study visit has been completed, except for a medical emergency.
  9. Participant must have a negative pregnancy test at screening and on Day 1 prior to the start of the ZULRESSO® infusion.

Exclusion Criteria:

  1. Participant has end stage renal failure.
  2. Participant has known allergy to progesterone or allopregnanolone or any excipients in the brexanolone injection.
  3. Participant is currently at risk of suicide, as judged by the investigator, or has attempted suicide associated with the current episode of PPD.

Sites / Locations

  • Sage Investigational Site
  • Virtual Site (recruiting nationwide)
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site
  • Sage Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ZULRESSO®

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.

Full Information

First Posted
September 17, 2021
Last Updated
June 26, 2023
Sponsor
Sage Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05059600
Brief Title
A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting
Official Title
Assessment of Safe-use Conditions for Administration of ZULRESSO in a Home Setting
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 8, 2021 (Actual)
Primary Completion Date
July 14, 2022 (Actual)
Study Completion Date
July 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sage Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ZULRESSO®
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ZULRESSO®
Other Intervention Name(s)
Allopregnanolone, Brexanolone, SAGE-547
Intervention Description
Intravenous infusion of ZULRESSO®.
Primary Outcome Measure Information:
Title
Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO®
Description
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
Title
Number of Use-Related Issues Related to the Home Administration of ZULRESSO®
Description
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
Title
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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
Title
Percentage of Participants With Medication Error
Description
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)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sage Investigational Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Virtual Site (recruiting nationwide)
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
Sage Investigational Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Facility Name
Sage Investigational Site
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Sage Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Sage Investigational Site
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov

Learn more about this trial

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

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