A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People
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
| Condition(s) | Postpartum Depression |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 mor |
| Who can participate | Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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. Note: Other protocol-defined Inclusion/Exclusion criteria may apply. |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Biogen |
| Locations | Cambridge, Massachusetts, United States |
| Start date | 2025-12-22 |
| NCT ID | NCT07398469 |
| Official listing | https://clinicaltrials.gov/study/NCT07398469 |