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Depression, Postpartum / Zuranolone · Observational Study
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective observational registry study of zuranolone in postpartum depression that has completed recruitment of 305 participants but has not yet reported results. The primary outcome is change in Edinburgh Postnatal Depression Scale (EPDS) score from baseline to Day 15 of treatment; secondary outcomes include EPDS changes at Days 3, 45, and 90, and concomitant medication use and breastfeeding patterns.
Observational. Depression, Postpartum; Female; age from 18 Years. Intervention: Cohort 1; Cohort 2. n = 305. 1 site: United States.
This is a prospective observational registry study of zuranolone in postpartum depression that has completed recruitment of 305 participants but has not yet reported results. The primary outcome is change in Edinburgh Postnatal Depression Scale (EPDS) score from baseline to Day 15 of treatment; secondary outcomes include EPDS changes at Days 3, 45, and 90, and concomitant medication use and breastfeeding patterns.
Recruitment from a single pharmacy database (CVS Specialty Pharmacy) may not represent all postpartum depression patients or treatment patterns.
This observational study will provide real-world data on the trajectory of EPDS scores in postpartum depression patients receiving zuranolone and patterns of concomitant medication use and breastfeeding. However, the lack of a control group and observational design limit causal inference; results should be interpreted as descriptive rather than definitive evidence of efficacy.
This is a registry record for a prospective observational study with no results reported; recruitment is complete but outcome data have not yet been published or posted.
As stated by the source record.
Quoted from the source exactly as published.
This observational study will provide real-world data on the trajectory of EPDS scores in postpartum depression patients receiving zuranolone and patterns of concomitant medication use and breastfeeding. However, the lack of a control group and observational design limit causal inference; results should be interpreted as descriptive rather than definitive evidence of efficacy.
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 (NCT07047820). This is a study registration, not published results. Lead sponsor: Biogen. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 305 participants (ACTUAL). Conditions: Depression, Postpartum. Interventions: DRUG: Zuranolone. Primary outcome measures: Cohorts 1 and 2: Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) at Day 15 , Baseline (Day 0), Day 15. Brief summary: In this study, researchers will learn more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD. After giving birth, adults with PPD can suffer from symptoms such as tiredness, sadness, and a loss of interest in their daily activities. This study is known as an observational study, which means it collects health information about study participants after a healthcare professional has already prescribed treatment. Participants for this study will be found in the United States using a database from Consumer Value Store (CVS) Specialty Pharmacy. This will include anyone who was prescribed zuranolone between June 2025 and May 2026 and who filled the prescription within 1 year after the end of their pregnancy. The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be measured using a questionnaire completed by participants called the Edinburgh Postnatal Depression Scale, also known as the EPDS. A higher score on the EPDS may indicate more severe PPD symptoms. The main question researchers want to answer in this study is: \- Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15? Researchers will also learn more about: * Changes in participants' EPDS scores from before treatment to Day 3, Day 45, and Day 90, which is 30 days after treatment ends. * How many participants breastfeed their babies while taking zuranolone * How many participants do not start new medicine after finishing their zuranolone treatment * How many participants take new medicines after finishing zuranolone * How many participants already tried other medicines for their depression symptoms before joining this study * How many participants take other medicines in general while taking zuranolone * Characteristics of participants' treatment use during the study This study will be done as follows: * People who fill their zuranolone prescription through CVS Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study. * Those who agree to take part will answer written questions about their symptoms using the EPDS tool. 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 tools, 3 days, 15 days, 45 days, and 90 days after taking the first dose of zuranolone.
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