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

NCT07398469 | Recruiting FDA Drug

• 1 other identifier: US-ZRN-12376
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Postpartum Depression

Outcome Measures

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.

  Baseline (Day 0), Day 15

Secondary Outcomes (5)

• Change From Baseline in the EPDS Score at Days 45 and 90

  Baseline (Day 0), Days 45 and 90

• Change From Baseline in the EPDS Score at Days 15, 45, and 90 in Participants With Moderate Severity

  Baseline (Day 0), Days 15, 45 and 90

• Number of Participants With no New Initiation of Medication After Completion of Zuranolone

  At Days 45 and 90

• Number of Participants With Moderate Postpartum Depression (PPD) Severity and no New Initiation of Medication After Completion of Zuranolone

  At Days 45 and 90

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

  At Day 45

Study Arms (1)

Zuranolone

Participants who are prescribed zuranolone for PPD will be contacted for enrolment.

Drug: Zuranolone

Interventions

Zuranolone DRUG

Administered orally

Also known as: Zurzuvae, BIIB125

Zuranolone

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Biogen

Cambridge, Massachusetts, 02142, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum

Interventions

zuranolone

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Central Study Contacts

US Biogen Clinical Trial Center

CONTACT

866-633-4636; clinicaltrials@biogen.com

Global Biogen Clinical Trial Center

CONTACT

clinicaltrials@biogen.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 10, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): March 29, 2027
• Study Completion (Estimated): March 29, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)