NCT07398469 A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
| NCT ID | NCT07398469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biogen |
| Condition | Postpartum Depression |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-12-22 |
| Primary Completion | 2027-03-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-12-22 with a primary completion date of 2027-03-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 : * Changes in participants' EPDS scores at Day 45 and Day 90 in the study * Changes in EPDS scores at Day 15, Day 45, and Day 90 in a group of participants who have moderately severe PPD before starting zuranolone * How many participants breastfeed their babies while taking zuranolone * How many participants report not starting new medicine after finishing their zuranolone treatment The study will be done as follows: * People with PPD who get a new zuranolone prescription through Accredo Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study. * Before taking their first dose of zuranolone, participants will be asked to answer written questions about their symptoms using the online EPDS survey. 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 survey, 15 days, 45 days, and 90 days after taking the first dose of zuranolone. Each survey will take about 10-15 minutes to finish.
Eligibility Criteria
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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Biogen
Frequently Asked Questions
Who can join the NCT07398469 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postpartum Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07398469 currently recruiting?
Yes, NCT07398469 is actively recruiting participants. Contact the research team at clinicaltrials@biogen.com for enrollment information.
Where is the NCT07398469 trial being conducted?
This trial is being conducted at Cambridge, United States.
Who is sponsoring the NCT07398469 clinical trial?
NCT07398469 is sponsored by Biogen. The principal investigator is Medical Director at Biogen. The trial plans to enroll 200 participants.
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