Clinical trial NCT05059600: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postpartum Depression
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-09-28
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation
timeFrame: Up to Day 3
Secondary outcomes:
measure: Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO®
timeFrame: Up to Day 3
measure: Number of Use-Related Issues Related to the Home Administration of ZULRESSO®
timeFrame: Up to Day 3
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Day 3
measure: Percentage of Participants With Medication Error
timeFrame: At screening and during the study (Up to Day 3)
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Sage Investigational Site
state: California
city: Culver City
country: United States
facility: Virtual Site (recruiting nationwide)
state: California
city: Miramar
country: United States
facility: Sage Investigational Site
state: Florida
city: Pompano Beach
country: United States
facility: Sage Investigational Site
state: Florida
city: New York
country: United States
facility: Sage Investigational Site
state: New York
city: League City
country: United States
facility: Sage Investigational Site
state: Texas
Study officials:
References: