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A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
NCT07398469 · View on ClinicalTrials.gov ↗
Study 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 backgr
Conditions Studied
Interventions
- DRUG Zuranolone
Study Locations (1)
Massachusetts
- Biogen — Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-12-22 |
| Est. Completion | 2027-03-29 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07398469
The ClinicalTrials.gov registry entry for NCT07398469 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Postpartum Depression appearing as the primary indexed condition, and to 1 intervention — of which Zuranolone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07398469 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07398469 about?
NCT07398469 is a clinical study titled "A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone". 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 lik...
What is the current status of trial NCT07398469?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2025-12-22. Estimated completion is 2027-03-29.
What conditions does trial NCT07398469 study?
This clinical trial studies the following conditions: Postpartum Depression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07398469?
The interventions under investigation include: Zuranolone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07398469?
This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07398469 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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