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

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Biogen
Study ID
NCT07398469
Status
Recruiting
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Conditions

  • Postpartum Depression

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 22, 2025
Status verified
Feb 2026
Primary completion
Mar 29, 2027
Completion
Mar 29, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Zuranolone
    Participants who are prescribed zuranolone for PPD will be contacted for enrolment.

Primary Outcome Measure

Change From Baseline in the Edinburgh Postnatal Depression Scale (EPDS) Score at Day 15 [ Time Frame: Baseline (Day 0), Day 15 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
BiogenCambridgeMassachusetts02142
Kebede Beyene (PRINCIPAL_INVESTIGATOR)

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By research site
Biogen· Cambridge, MA

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