How zuranolone affects postpartum depression symptoms in people who took it within a year after pregnancy
Prospective, Observational Survey Study Assessing Effectiveness of Zuranolone in Improving PPD Symptoms in the Real-world Setting
Biogen · NCT07047820
This study will test whether zuranolone reduces postpartum depression symptoms in adults who were prescribed it within one year after their pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Biogen (industry) |
| Locations | 1 site (Woonsocket, Rhode Island) |
| Trial ID | NCT07047820 on ClinicalTrials.gov |
What this trial studies
This is an observational study using CVS Specialty Pharmacy records to identify U.S. adults who filled a zuranolone prescription between June 2025 and May 2026 within 12 months after the end of pregnancy. Participants complete self-reported questionnaires, with the primary outcome measured by the Edinburgh Postnatal Depression Scale (EPDS) at Day 15 after starting treatment. Secondary outcomes include EPDS at Day 45, a subgroup analysis of participants with moderate baseline PPD, breastfeeding status at Day 45, and characterization of treatment use over 45 days via self-report. People with recent prior exposure to zuranolone or brexanolone, bipolar disorder, or who fail to complete baseline surveys before a second dose are excluded per protocol.
Who should consider this trial
Good fit: Ideal candidates are U.S. adults diagnosed with postpartum depression who received and filled a zuranolone prescription through CVS Specialty Pharmacy within 12 months after pregnancy and can complete online questionnaires independently.
Not a fit: Patients with a history of bipolar disorder, recent prior brexanolone or zuranolone exposure, who received two or more doses before screening, or whose pregnancy ended more than 12 months ago are unlikely to be eligible or benefit from this study.
Why it matters
Potential benefit: If successful, the study could show that zuranolone leads to meaningful symptom improvement in the first two weeks after treatment, supporting its use as a rapid option for postpartum depression.
How similar studies have performed: Related neuroactive steroid treatments like brexanolone have shown benefit in PPD, and prior zuranolone studies have suggested symptom improvement though results across trials have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Adults who were prescribed and had one successful fill for zuranolone within 12 months following end of pregnancy for the treatment of PPD from June 2025 to May 2026 through CVS Specialty Pharmacy. * Currently reside in the United States. * Able to complete the questionnaires independently. Key Exclusion Criteria: * Prior fill of zuranolone or brexanolone in last 12 months. * Participants with 2 or more doses of zuranolone at the time of screening. * Current or history of bipolar disorder. * Failure to complete baseline surveys prior to 2nd dose of zuranolone. * Pregnancy that ended more than 12 months ago. Other protocol-defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Woonsocket, Rhode Island
- CVS Health — Woonsocket, Rhode Island, United States (RECRUITING)
Study contacts
- Study coordinator: US Biogen Clinical Trial Center
- Email: clinicaltrials@biogen.com
- Phone: 866-633-4636
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression, Postpartum