Zuranolone / Postpartum Depression · Observational Study
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned observational registry study enrolling 300 postpartum depression patients starting zuranolone to track symptom changes via EPDS questionnaire over 90 days. No results are yet reported in this registry record; the entry describes study design and procedures only.
Observational. Postpartum Depression; Female; age from 18 Years. Intervention: Cohort 1; Cohort 2. n = 300. 1 site: United States.
This is a planned observational registry study enrolling 300 postpartum depression patients starting zuranolone to track symptom changes via EPDS questionnaire over 90 days. No results are yet reported in this registry record; the entry describes study design and procedures only.
Recruitment from a single specialty pharmacy database may not represent the general PPD population.
Clinicians should await published results from this observational study; the registry entry indicates planned data collection but provides no evidence on zuranolone's efficacy or safety in postpartum depression.
This is a registry record for a planned observational study with no results reported; it describes study design and procedures only, not outcomes or efficacy.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should await published results from this observational study; the registry entry indicates planned data collection but provides no evidence on zuranolone's efficacy or safety in postpartum depression.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07398469). This is a study registration, not published results. Lead sponsor: Biogen. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Postpartum Depression. Interventions: DRUG: Zuranolone. Primary outcome measures: Change From Baseline in the Edinburgh Postnatal Depression Scale (EPDS) Score at Day 15 , Baseline (Day 0), Day 15. 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 3, Day 45 and Day 90 in the study * Changes in EPDS scores at Day 3, 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. Some participants will also be asked to complete a survey about 3 days after starting treatment. Each survey will take about 10-15 minutes to finish.
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