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

Part of paid clinical trials in Woonsocket, Rhode Island.

Sponsor
Biogen
Study ID
NCT07047820
Status
Recruiting
Apply to this trial

Conditions

  • Depression, Postpartum

Eligibility Criteria

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

Interventions

  • Zuranolone — DRUG
    Administered as specified in the treatment arm

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Jul 2025
Primary completion
Aug 24, 2026
Completion
Aug 24, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CVS HealthWoonsocketRhode Island02895
800-746-7287
Laura Lupton (PRINCIPAL_INVESTIGATOR)

Find similar trials in Woonsocket, RI

By research site
CVS Health· Woonsocket, RI

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