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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 :
The study will be done as follows:
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zuranolone | Participants who are prescribed zuranolone for PPD will be contacted for enrolment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zuranolone | Drug | Administered orally |
|
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the EPDS Score at Days 45 and 90 | 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 45 and 90 |
| Change From Baseline in the EPDS Score at Days 15, 45, and 90 in Participants With Moderate Severity |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: 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 |
|---|---|---|---|---|---|---|
| Biogen | Recruiting | Cambridge | Massachusetts | 02142 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on htps://www.biogentrialtransparency.com/
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C000634505 | zuranolone |
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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, 45 and 90 |
| 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 With Moderate Postpartum Depression (PPD) Severity and 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 |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |