Actively Recruiting
A Longitudinal Online Survey of Patient-Reported Changes in Postpartum Depression Symptoms Following Zuranolone Use
Led by Biogen · Updated on 2026-02-10
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how symptoms of postpartum depression (PPD) change in people starting treatment with zuranolone, a drug prescribed for PPD. This observational study collects health information without altering medical care, focusing on people in the United States who have a new prescription for zuranolone and were pregnant within the last 12 months. The main goal is to understand changes in depression symptoms using the Edinburgh Postnatal Depression Scale (EPDS). Participants who receive a zuranolone prescription through Accredo Specialty Pharmacy will be invited to join the study. Before their first dose, they will complete online surveys about their symptoms and background. They must start taking zuranolone within 7 days of joining. Follow-up surveys using the EPDS will take place at days 15, 45, and 90 after starting the medication to track symptom changes and other factors like breastfeeding and medication use. Participants will provide information through multiple online surveys, each taking about 10 to 15 minutes. Researchers will assess changes in EPDS scores at several time points, breastfeeding status during treatment, and medication usage after zuranolone completion. The study aims to gather detailed, patient-reported data over a 90-day period without changing participants' usual medical care.
CONDITIONS
Brief Title
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with a prescription for zuranolone via Accredo Specialty Pharmacy.
- Recent pregnancy in the last 12 months.
- Confirmed diagnosis of postpartum depression.
- Able to complete questionnaires by themselves in English.
You will not qualify if you...
- Prior fill of zuranolone or brexanolone in last 12 months.
- Participants who have taken one or more doses of zuranolone at study screening.
- Current or history of bipolar disorder.
- Failure to complete baseline (Day 0) surveys.
- Declined to consent.
- Pregnancy that 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 screening and enrollment visit (online)
Duration - 90 days
Participants complete online surveys to report changes in postpartum depression symptoms and treatment usage over time.
Surveys completed at Day 0, Day 15, Day 45, and Day 90
Trial Site Locations
Total: 1 location
1
Biogen
Cambridge, Massachusetts, United States, 02142
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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