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

Not yet recruiting

• Conditions: Depression, Postpartum

• Registration Number: NCT07047820
• Lead Sponsor: Biogen

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.

Detailed Description

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

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study Start: 2025-06-26
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02
• Primary Completion: 2026-08-24
• Study Completion: 2026-08-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• 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.

Key

Exclusion Criteria

• 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.

Other protocol-defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) at Day 15	Baseline (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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in EPDS at Day 45	Baseline (Day 0), Day 45	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.
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
Number of Participants That Self-Report History of Medication Use for Depression	Day 0
Number of Participants With Moderate PPD Severity That Self-Report History of Medication Use for Depression	Day 0
Number of Participants With Moderate PPD Severity That Self-Report Prior Lines of Treatment for Their Current PPD Episode	Day 0
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	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.
Number of Participants That Self-Report Prior Lines of Treatment for Their Current PPD Episode	Day 0
Number of Participants With Moderate PPD Severity That Self-Report Concomitant Medication Use With Zuranolone for the Treatment of PPD	Day 0
Number of Participants That Self-Report Concomitant Medication Use With Zuranolone for the Treatment of PPD	Day 0