Poster
178
(#178) Prospective, observational survey study to assess real-world effectiveness of zuranolone in improving symptoms of postpartum depression (PPD) - study design and initial participant characteristics
Psych Congress 2025
Abstract: Background: Postpartum depression (PPD) symptoms affect ~13.2% of US births. This study explores effectiveness of zuranolone, a once-daily 14-day oral treatment for PPD. This interim analysis summarizes study design, demographic and clinical characteristics of an initial outreached participants.
Methods: Participants aged ≥ 18, diagnosed with PPD, with a pregnancy within the last 12 months and an initial fill of zuranolone through a national specialty pharmacy are invited to enroll. Participants complete the Edinburgh Postnatal Depression Scale (EPDS) when beginning (Day 0) and after completion of a 14-day course of zuranolone (Days 15 and 45). Study design captures initial zuranolone fills 06/26/2025 until a 200-sample size is reached. Treatment effectiveness will be based on improvement in EPDS scores.
Results: Through 07/29/2025, 37 participants had completed a baseline survey. Mean(±SD) age was 30 (±4) years. Most participants were White (n=31), with 3 identifying as Hispanic. Psychiatric comorbidities were reported by 29 participants, 27 used an antidepressant or antipsychotic for current PPD diagnosis, and 8 patients had a previous history of PPD. Baseline mean EPDS score was 19.0 (±4.2) with 4 participants reporting EPDS≤13,16 participants reporting moderate (EPDS 14-19) and 17 reporting severe (EPDS 20-30) PPD symptoms.
Conclusions: This ongoing prospective, observational patient-reported outcomes study assesses use of zuranolone in a real-world setting. At interim, 33 participants reported moderate or severe baseline symptoms. Final analyses will evaluate changes in PPD symptoms over time providing insights into real-world effectiveness of zuranolone.
Limitations: This is an active study; data reflect enrollment to date.
Short Description: This prospective, observational survey study assesses real-world symptom improvement among participants with postpartum depression (PPD) who initiate zuranolone, a 14-day oral therapy for adults with PPD. Participants with a recent pregnancy complete the Edinburgh Postnatal Depression Scale (EPDS) at baseline and multiple time points following zuranolone initiation to assess changes in PPD symptoms. The study highlights treatment outcomes and patient characteristics, offering insights into zuranolone's real-world effectiveness in the treatment of PPD.
Name of Sponsoring Organization(s): Biogen
Methods: Participants aged ≥ 18, diagnosed with PPD, with a pregnancy within the last 12 months and an initial fill of zuranolone through a national specialty pharmacy are invited to enroll. Participants complete the Edinburgh Postnatal Depression Scale (EPDS) when beginning (Day 0) and after completion of a 14-day course of zuranolone (Days 15 and 45). Study design captures initial zuranolone fills 06/26/2025 until a 200-sample size is reached. Treatment effectiveness will be based on improvement in EPDS scores.
Results: Through 07/29/2025, 37 participants had completed a baseline survey. Mean(±SD) age was 30 (±4) years. Most participants were White (n=31), with 3 identifying as Hispanic. Psychiatric comorbidities were reported by 29 participants, 27 used an antidepressant or antipsychotic for current PPD diagnosis, and 8 patients had a previous history of PPD. Baseline mean EPDS score was 19.0 (±4.2) with 4 participants reporting EPDS≤13,16 participants reporting moderate (EPDS 14-19) and 17 reporting severe (EPDS 20-30) PPD symptoms.
Conclusions: This ongoing prospective, observational patient-reported outcomes study assesses use of zuranolone in a real-world setting. At interim, 33 participants reported moderate or severe baseline symptoms. Final analyses will evaluate changes in PPD symptoms over time providing insights into real-world effectiveness of zuranolone.
Limitations: This is an active study; data reflect enrollment to date.
Short Description: This prospective, observational survey study assesses real-world symptom improvement among participants with postpartum depression (PPD) who initiate zuranolone, a 14-day oral therapy for adults with PPD. Participants with a recent pregnancy complete the Edinburgh Postnatal Depression Scale (EPDS) at baseline and multiple time points following zuranolone initiation to assess changes in PPD symptoms. The study highlights treatment outcomes and patient characteristics, offering insights into zuranolone's real-world effectiveness in the treatment of PPD.
Name of Sponsoring Organization(s): Biogen
