RecruitingNCT07398469

A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone

A Longitudinal Online Survey of Patient-Reported Changes in Postpartum Depression Symptoms Following Zuranolone Use


Sponsor

Biogen

Enrollment

200 participants

Start Date

Dec 22, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

In this study, researchers will learn how postpartum depression symptoms may change after people first start taking zuranolone. This is a drug available for doctors to prescribe for people with postpartum depression, also known as PPD. After giving birth, people with PPD can suffer from symptoms like tiredness, sadness, and a loss of interest in their daily activities. This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will be found in the United States using a database from Accredo Specialty Pharmacy. This will include anyone who has a new prescription for zuranolone and were pregnant in the last 12 months before joining the study. The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be done using a questionnaire called the Edinburgh Postnatal Depression Scale, also known as the EPDS. The main question that researchers want to answer is: • Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15? Researchers will also learn about : * Changes in participants' EPDS scores at Day 45 and Day 90 in the study * Changes in EPDS scores at Day 15, Day 45, and Day 90 in a group of participants who have moderately severe PPD before starting zuranolone * How many participants breastfeed their babies while taking zuranolone * How many participants report not starting new medicine after finishing their zuranolone treatment The study will be done as follows: * People with PPD who get a new zuranolone prescription through Accredo Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study. * Before taking their first dose of zuranolone, participants will be asked to answer written questions about their symptoms using the online EPDS survey. They will also answer other survey questions about their background, environment, and general health information. Participants must take their first dose of zuranolone within 7 days of joining the study. * Participants will then be asked to answer questions using the EPDS survey, 15 days, 45 days, and 90 days after taking the first dose of zuranolone. Each survey will take about 10-15 minutes to finish.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking how well a medication called zuranolone works for women with postpartum depression (depression after childbirth) in a real-world setting — outside of a clinical trial — by asking participants to complete questionnaires about their symptoms over time after starting the medication. **You may be eligible if...** - You have a prescription for zuranolone through Accredo Specialty Pharmacy - You gave birth within the past 12 months - You have been diagnosed with postpartum depression (PPD) - You are able to fill out questionnaires in English on your own - You have not yet taken any doses of zuranolone at the time of enrollment **You may NOT be eligible if...** - You have already taken zuranolone or brexanolone in the past 12 months - You have already started taking zuranolone before enrolling in the study - You are unable to complete the questionnaires independently in English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZuranolone

Administered orally


Locations(1)

Biogen

Cambridge, Massachusetts, United States

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NCT07398469


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