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

A Longitudinal Online Survey of Patient-Reported Changes in Postpartum Depression Symptoms Following Zuranolone Use

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression
• Intervention / Treatment: Drug: Zuranolone

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: US Biogen Clinical Trial Center; Phone Number: 866-633-4636; Email: clinicaltrials@biogen.com
• Study Contact Backup: Name: Global Biogen Clinical Trial Center; Email: clinicaltrials@biogen.com

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02142
      • Recruiting
      • Biogen
      • Principal Investigator: Kebede Beyene

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Administered orally; Other Names: Zurzuvae; BIIB125
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; Administered orally; Other Names: Zurzuvae; BIIB125

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 0), Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With no New Initiation of Medication After Completion of Zuranolone	This outcome measure will be self-reported by participants.	At Days 45 and 90
Number of Participants Feeding Their Baby Breastmilk as Usual While Taking Zuranolone	This outcome measure will be self-reported by participants.	At Day 45
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.	Baseline (Day 0), Days 3 (Cohort 2 only), 45 and 90
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.	Baseline (Day 0), Days 3 (Cohort 2 only), 15, 45 and 90
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.	Baseline up to Day 90
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.	At Days 45 and 90
Number of Participants Achieving Remission		At Days 15, Day 45, and Day 90
Number of Participants Achieving Remission by Baseline Severity		At Days 15, Day 45, and Day 90

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): March 29, 2027
• Study Completion (Estimated): March 29, 2027

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum; zuranolone
• Other Study ID Numbers: US-ZRN-12376

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on htps://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No