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

NCT07047820 | Recruiting FDA Drug

• 1 other identifier: US-ZRN-12349
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Postpartum

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) 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 (11)

• Change From Baseline in EPDS at Day 45

  Baseline (Day 0), Day 45

• Change From Baseline in EPDS in Participants With Moderate Postpartum Depression (PPD) Severity at Days 15 and 45

  Baseline (Day 0), Days 15 and 45

• Number of Participants That Self-Report no New Initiation of Medication After Completion of Zuranolone

  Day 45

• Number of Participants With Moderate PPD Severity That Self-Report no New Initiation of Medication After Completion of Zuranolone

  Day 45

• Number of Participants That Self-Report Feeding Their Baby Breastmilk as Usual While Taking Zuranolone

  Day 45

Study Arms (1)

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.

Drug: Zuranolone

Interventions

Zuranolone DRUG

Administered as specified in the treatment arm

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

CVS Health

Woonsocket, Rhode Island, 02895, 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: June 25, 2025
• First Posted: July 2, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): August 24, 2026
• Study Completion (Estimated): August 24, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)