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RecruitingNCT07398469Updated Sep 8, 2026

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

An observational study in Postpartum Depression, sponsored by Biogen. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Biogen · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
Female
01

Study summary

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 3, Day 45 and Day 90 in the study
  • Changes in EPDS scores at Day 3, 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. Some participants will also be asked to complete a survey about 3 days after starting treatment. Each survey will take about 10-15 minutes to finish.
Read the detailed description

The primary objective of this study is to assess the reduction in Postpartum Depression (PPD) symptoms via the Edinburgh Postnatal Depression Scale (EPDS) at Day 15 in study participants. The secondary objectives are to assess the reduction in PPD symptoms via the EPDS at Day 3 (cohort 2 only), to assess the reduction in PPD symptoms via the EPDS at Day 45 and Day 90 in study participants, reduction in PPD symptoms via the EPDS at Day 15,Day 45, and Day 90 in a subgroup of participants with moderate PPD at baseline, to assess breastfeeding status during treatment with zuranolone as reported at Day 45 and to characterize treatment usage across the 90-day period via self-reported survey questions.

02

Conditions studied

  • Postpartum Depression
03

In context

Depression, Postpartum

569 studies on the registry are indexed under Depression, Postpartum; 134 are open to participants now.

This study's planned enrollment of 300 is above the median of 223 across 100 observational studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 50 (50%) have results posted.

Browse Biogen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants prescribed zuranolone who consent to participate in this study and meet all of the inclusion criteria, none of the exclusion criteria, and complete baseline (Day 0) will be considered enrolled in this study.

Eligibility criteria

Key Inclusion Criteria:

  • Participants with a prescription for zuranolone via Accredo Specialty Pharmacy.
  • Recent pregnancy in the last 12 months.
  • Confirmed diagnosis of PPD.
  • Able to complete the questionnaires by themselves in English.

Key Exclusion Criteria:

  • Prior fill of zuranolone or brexanolone in last 12 months.
  • Participants who have taken 1 or more doses of zuranolone at the time of study screening.
  • Current or history of bipolar disorder.
  • Failure to complete baseline (Day 0) surveys.
  • Declined to consent.
  • Pregnancy that ended more than 12 months ago.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cohort 1

    Participants who are prescribed zuranolone for PPD will be invited to an online survey to evaluate changes in EPDS score on Days 0, 15, 45 and 90.

    Drug: Zuranolone

  • Cohort 2

    Participants who are prescribed zuranolone for PPD will be invited to an online survey to evaluate changes in EPDS score on Days 0, 3, 15, 45 and 90.

    Drug: Zuranolone

Interventions

  • DrugZuranolone

    Administered orally

    Also known as: Zurzuvae, BIIB125

06

What researchers measure

Primary outcomes

  1. Change From Baseline in the Edinburgh Postnatal Depression Scale (EPDS) Score at 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.

    Time frame: Baseline (Day 0), Day 15

Secondary outcomes

  1. Change From Baseline in the EPDS Score

    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.

    Time frame: Baseline (Day 0), Days 3 (Cohort 2 only), 45 and 90

  2. Change From Baseline in the EPDS Score in Participants With Moderate Severity

    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.

    Time frame: Baseline (Day 0), Days 3 (Cohort 2 only), 15, 45 and 90

  3. Change From Baseline in the EPDS by Baseline Severity

    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.

    Time frame: Baseline up to Day 90

  4. Number of Participants With no New Initiation of Medication After Completion of Zuranolone

    This outcome measure will be self-reported by participants.

    Time frame: At Days 45 and 90

  5. Number of Participants who Report no New Initiation of Treatment After Completion of Zuranolone by Severity

    This outcome measure will be self-reported by participants.

    Time frame: At Days 45 and 90

  6. Number of Participants Feeding Their Baby Breastmilk as Usual While Taking Zuranolone

    This outcome measure will be self-reported by participants.

    Time frame: At Day 45

  7. Number of Participants Achieving Remission

    Time frame: At Days 15, Day 45, and Day 90

  8. Number of Participants Achieving Remission by Baseline Severity

    Time frame: At Days 15, Day 45, and Day 90

07

Study locations

1 of 1 sites recruiting
  • Biogen
    Cambridge, Massachusetts 02142, United States
    Recruiting
    • Kebede Beyene · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Mar 2027, 15 months after the start.

Of 52 observational studies under Depression, Postpartum, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 50. This study's planned 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2026
First posted
Feb 10, 2026
StartActual
Dec 22, 2025
Primary completionEst.
Mar 29, 2027
CompletionEst.
Mar 29, 2027
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07398469
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Feb 10, 2026
Start date
Dec 22, 2025
Primary completion
Mar 29, 2027 (estimated)
Completion
Mar 29, 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

US Biogen Clinical Trial Center
Contact
clinicaltrials@biogen.com
866-633-4636
Global Biogen Clinical Trial Center
Contact
clinicaltrials@biogen.com
Medical Director
study director · Biogen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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