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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zuranolone | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in EPDS at 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. | Baseline (Day 0), Day 45 |
| Change From Baseline in EPDS in Participants With Moderate Postpartum Depression (PPD) Severity at Days 15 and 45 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion criteria may apply.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Contact | 866-633-4636 | clinicaltrials@biogen.com | |
| Global Biogen Clinical Trial Center | Contact | clinicaltrials@biogen.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CVS Health | Recruiting | Woonsocket | Rhode Island | 02895 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on htps://www.biogentrialtransparency.com/
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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 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 |
| 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 That Self-Report Prior Lines of Treatment for Their Current PPD Episode | Day 0 |
| Number of Participants With Moderate PPD Severity That Self-Report Prior Lines of Treatment for Their Current PPD Episode | Day 0 |
| Number of Participants That Self-Report Concomitant Medication Use With Zuranolone for the Treatment of PPD | Day 0 |
| Number of Participants With Moderate PPD Severity That Self-Report Concomitant Medication Use With Zuranolone for the Treatment of PPD | Day 0 |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000634505 | zuranolone |
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