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Observational Study of Zuranolone for Postpartum Depression

This study is looking at how Zuranolone affects symptoms of postpartum depression (PPD) in women who have recently given birth. Zuranolone is a medication prescribed for PPD, which can cause tiredness, sadness, and loss of interest in daily activities. Researchers will observe women who have already been prescribed Zuranolone within one year after their pregnancy and filled their prescription through CVS Specialty Pharmacy between June 2025 and May 2026. The main goal is to see how much Zuranolone helps reduce PPD symptoms, measured by a questionnaire called the Edinburgh Postnatal Depression Scale (EPDS) after 15 days. This is an observational study, meaning researchers will collect health information after you've already started treatment.

Study design
This is an observational study with a planned enrollment of 200 participants. It collects health information after a healthcare professional has already prescribed treatment.
What's involved
You would need to be able to complete questionnaires independently. Your PPD symptoms will be assessed using the EPDS at Day 0 and Day 15.
Compensation
Not stated in the trial record.
Follow-up
Your PPD symptoms will be assessed at Day 15 and Day 45. Breastfeeding status and treatment usage will also be characterized at Day 45.

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NCT07047820

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

Recruiting
Not specifiedAges 18+Observational
Biogen
~200 participants
Updated 2025-08-03 on ClinicalTrials.gov
What's tested:Zuranolone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) at Day 15
Measured over Baseline (Day 0), Day 15

Conditions

Depression, Postpartum

Explore related trials

Postpartum Depression

Where it's being run

1 sites across 1 states
Rhode Island1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Biogen

Who to contact

US Biogen Clinical Trial Center
[email protected]
866-633-4636
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults who were prescribed and had one successful fill for zuranolone within 12 months following end of pregnancy for the treatment of PPD from June 2025 to May 2026 through CVS Specialty Pharmacy.
Currently reside in the United States.
Able to complete the questionnaires independently.

Exclusion

Prior fill of zuranolone or brexanolone in last 12 months.
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.

What this trial measures

  • Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) at Day 15Baseline (Day 0), Day 15

    EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms.