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

NCT05059600 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 547-PPD-404
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to Day 3

Secondary Outcomes (4)

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

  Up to Day 3

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

  Up to Day 3

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

  Up to Day 3

• Percentage of Participants With Medication Error

  At screening and during the study (Up to Day 3)

Study Arms (1)

ZULRESSO®

EXPERIMENTAL

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.

Drug: ZULRESSO®

Interventions

ZULRESSO® DRUG

Intravenous infusion of ZULRESSO®.

Also known as: Allopregnanolone, Brexanolone, SAGE-547

ZULRESSO®

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (6)

Sage Investigational Site

Culver City, California, 90230, United States

Location

Virtual Site (recruiting nationwide)

Culver City, California, 90230, United States

Location

Sage Investigational Site

Miramar, Florida, 33029, United States

Location

Sage Investigational Site

Pompano Beach, Florida, 33060, United States

Location

Sage Investigational Site

New York, New York, 10036, United States

Location

Sage Investigational Site

League City, Texas, 77573, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

brexanolone; Pregnanolone

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Medical Monitor
• Organization: Sage Therapeutics

info@sagerx.com

(617) 299-8380

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 28, 2021
• Study Start: October 8, 2021
• Primary Completion: July 14, 2022
• Study Completion: July 14, 2022
• Last Updated: September 15, 2025
• Results First Posted: July 19, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)