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
NCT ID: NCT07047820
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-06-30
2026-08-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Zuranolone
Participants who are prescribed zuranolone for PPD and are filling zuranolone through a consumer value store (CVS) specialty pharmacy will be contacted through email or the call center for enrollment in the study.
Zuranolone
Administered as specified in the treatment arm
Interventions
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Zuranolone
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently reside in the United States.
* Able to complete the questionnaires independently.
Exclusion Criteria
* Participants with 2 or more doses of zuranolone at the time of screening.
* Current or history of bipolar disorder.
* Failure to complete baseline surveys prior to 2nd dose of zuranolone.
* Pregnancy that ended more than 12 months ago.
18 Years
FEMALE
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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CVS Health
Woonsocket, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Other Identifiers
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US-ZRN-12349
Identifier Type: -
Identifier Source: org_study_id
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