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

NCT07398469 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Zuranolone

Administered orally

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2027-03-29
Completion
2027-03-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07398469 on ClinicalTrials.gov