Actively Recruiting
Observational Survey Study of Zuranolone Effects on Postpartum Depression Symptoms in Real-World Setting
Led by Biogen · Updated on 2025-08-03
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to learn more about how zuranolone affects postpartum depression (PPD) symptoms in adults who took the medication within one year after the end of their pregnancy. PPD can cause tiredness, sadness, and loss of interest in daily activities. The study is observational, collecting health information from participants who have already been prescribed zuranolone through CVS Specialty Pharmacy in the United States between June 2025 and May 2026. Participants will be contacted by email or phone after filling their zuranolone prescription to ask if they wish to join the study. Those who agree will complete questionnaires about their symptoms using the Edinburgh Postnatal Depression Scale (EPDS) and answer other surveys about their health and environment. Participants must take their first dose of zuranolone within seven days of joining. The study will follow them by collecting EPDS scores at baseline, Day 15, and Day 45, which is 30 days after treatment ends. Throughout the study, researchers will monitor changes in PPD symptoms using EPDS scores and assess breastfeeding status during treatment. They will also gather information about medication use before, during, and after zuranolone treatment. Participants will complete surveys independently, and the study focuses on understanding how zuranolone influences PPD symptoms over the 45-day period.
CONDITIONS
Brief Title
A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults prescribed zuranolone for postpartum depression who filled at least one prescription within 12 months after pregnancy
- Currently live in the United States
- Able to complete questionnaires independently
You will not qualify if you...
- Prior zuranolone or brexanolone use in the last 12 months
- Have received two or more doses of zuranolone at screening
- Current or past diagnosis of bipolar disorder
- Did not complete baseline surveys before second zuranolone dose
- Pregnancy ended more than 12 months ago
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote or in-person)
Duration - 45 days
Participants are observed while taking zuranolone for postpartum depression and complete self-reported surveys to assess symptoms and treatment usage.
Surveys at Day 0, Day 15, and Day 45
Trial Site Locations
Total: 1 location
1
CVS Health
Woonsocket, Rhode Island, United States, 02895
Actively Recruiting
Research Team
U
US Biogen Clinical Trial Center
G
Global Biogen Clinical Trial Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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