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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

NCT07047820 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-08-03

No results posted yet for this study

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.

Conditions

  • Depression, Postpartum

Interventions

DRUG

Zuranolone

Administered as specified in the treatment arm

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-08-24
Completion
2026-08-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT07047820 on ClinicalTrials.gov