RecruitingNCT07047820

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

Prospective, Observational Survey Study Assessing Effectiveness of Zuranolone in Improving PPD Symptoms in the Real-world Setting


Sponsor

Biogen

Enrollment

200 participants

Start Date

Jun 30, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

In this study, researchers will learn more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD. After giving birth, adults with PPD can suffer from symptoms such as tiredness, sadness, and a loss of interest in their daily activities. This study is known as an observational study, which means it collects health information about study participants after a healthcare professional has already prescribed treatment. Participants for this study will be found in the United States using a database from CVS Specialty Pharmacy. This will include anyone who was prescribed zuranolone between June 2025 and May 2026 and who filled the prescription within 1 year after the end of their pregnancy. The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be measured using a questionnaire completed by participants called the Edinburgh Postnatal Depression Scale, also known as the EPDS. A higher score on the EPDS may indicate more severe PPD symptoms. The main question researchers want to answer in this study is: \- Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15? Researchers will also learn more about: * Changes in participants' EPDS scores from before treatment to Day 45, which is 30 days after treatment ends. * How many participants breastfeed their babies while taking zuranolone * How many participants do not start new medicine after finishing their zuranolone treatment * How many participants take new medicines after finishing zuranolone * How many participants already tried other medicines for their depression symptoms before joining this study * How many participants take other medicines in general while taking zuranolone This study will be done as follows: People who fill their zuranolone prescription through CVS Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study. Those who agree to take part will answer written questions about their symptoms using the EPDS tool. 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 tools, 15 days and 45 days after taking the first dose of zuranolone.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world information about how well zuranolone — a recently approved medication for postpartum depression (PPD) — works in women who have been prescribed it through CVS Specialty Pharmacy after the end of a pregnancy. The goal is to better understand outcomes in a real clinical setting, not just in a controlled trial. **You may be eligible if...** - You were prescribed zuranolone within 12 months after the end of your pregnancy (June 2025 to May 2026) for postpartum depression through CVS Specialty Pharmacy - You currently live in the United States - You can complete online questionnaires independently **You may NOT be eligible if...** - You have previously taken zuranolone or brexanolone in the last 12 months - You have already taken 2 or more doses of zuranolone before screening - You have a current or prior history of bipolar disorder - Your pregnancy ended more than 12 months ago 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 as specified in the treatment arm


Locations(1)

CVS Health

Woonsocket, Rhode Island, United States

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NCT07047820


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