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NCT07398469 · ClinicalTrials.gov registry record
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
A clinical trial of Postpartum Depression, sponsored by Biogen.
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT07398469: Recruiting study of Postpartum Depression, sponsored by Biogen.
NCT07398469 is a study of Postpartum Depression that is actively recruiting participants, run by Biogen. The registered enrollment target is 200 participants, below the 471-participant average among 47 other Postpartum Depression trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07398469, a study of Postpartum Depression, is actively recruiting participants, sponsored by Biogen.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
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.
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 |
What NCT07398469 shows while recruiting
NCT07398469 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 471-participant average among 47 other Postpartum Depression trials with a reported enrollment target (58% lower).
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.
NCT07398469 reports a single indexed study location in Massachusetts.
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.
What interventions are being tested in trial NCT07398469?
The interventions under investigation include: Zuranolone (DRUG).
Who is sponsoring clinical trial NCT07398469?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Postpartum Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07398469's enrollment target sits among peer trials
200 19th of 47 higher than 29 of 47 other Postpartum Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postpartum Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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