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

Phase 4

Completed

• Conditions: Postpartum Depression
• Interventions: Drug: ZULRESSO®

• Registration Number: NCT05059600
• Lead Sponsor: Sage Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-28
• Study Start: 2021-10-08
• Primary Completion: 2022-07-14
• Study Completion: 2022-07-14
• Status Verified: 2023-06
• Results First Submitted: 2023-06-26
• Results First Submitted QC: 2023-06-26
• Last Update Submitted: 2023-06-26
• Results First Posted: 2023-07-19
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZULRESSO®	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation	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 Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	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.
Percentage of Participants With Medication Error	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.
Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO®	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
Number of Use-Related Issues Related to the Home Administration of ZULRESSO®	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.

Trial Locations

Locations (2)

Sage Investigational Site; 🇺🇸 League City, Texas, United States

Virtual Site (recruiting nationwide); 🇺🇸 Culver City, California, United States