๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-04

A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone (NCT07398469)

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

๐ŸŸข Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: Biogen

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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: โ€ข 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.

Who can join: Review the eligibility criteria below.

Location: Biogen โ€” Cambridge, Massachusetts

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Biogen โ€” Cambridge, Massachusetts

๐Ÿ“ž Contact the Study Coordinator

Phone: (866) 633-4636

Email: clinicaltrials@biogen.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—