Tracking postpartum depression symptoms after starting zuranolone

A Longitudinal Online Survey of Patient-Reported Changes in Postpartum Depression Symptoms Following Zuranolone Use

This study will see how postpartum depression symptoms change in people who start taking zuranolone within a year after giving birth.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Biogen (industry)
• Locations: 1 site (Cambridge, Massachusetts)
• Trial ID: NCT07398469 on ClinicalTrials.gov

What this trial studies

This observational study will follow people in the United States who have a new prescription for zuranolone to track symptom changes over 90 days. Participants are identified via Accredo Specialty Pharmacy and complete the Edinburgh Postnatal Depression Scale (EPDS) at baseline, Day 15 (primary), Day 45, and Day 90, along with surveys on breastfeeding and medication use. The study does not change participants' medical care and relies on self-reported outcomes and treatment patterns. People with recent prior fills of zuranolone or brexanolone, a history of bipolar disorder, or an inability to complete English questionnaires are excluded.

Who should consider this trial

Good fit: Ideal candidates are people in the U.S. within 12 months after pregnancy who have a confirmed diagnosis of postpartum depression and a new prescription for zuranolone, can complete surveys in English, and have not recently used zuranolone or brexanolone.

Not a fit: People with a history of bipolar disorder, those who already filled or started zuranolone or brexanolone in the past 12 months, non-English speakers, or those more than 12 months postpartum are unlikely to qualify or benefit from this observational data.

Why it matters

Potential benefit: If successful, the study could give clinicians and patients clearer, real-world information on how quickly and how long zuranolone may help postpartum depression symptoms and how it is used during the first 90 days.

How similar studies have performed: Previous clinical trials of zuranolone and related neuroactive steroids have shown rapid symptom improvements in some people with PPD, but long-term and real-world data like this are limited.

Eligibility criteria

Key Inclusion Criteria:

* Participants with a prescription for zuranolone via Accredo Specialty Pharmacy.
* Recent pregnancy in the last 12 months.
* Confirmed diagnosis of PPD.
* Able to complete the questionnaires by themselves in English.

Key Exclusion Criteria:

* Prior fill of zuranolone or brexanolone in last 12 months.
* Participants who have taken 1 or more doses of zuranolone at the time of study screening.
* Current or history of bipolar disorder.
* Failure to complete baseline (Day 0) surveys.
* Declined to consent.
* Pregnancy that ended more than 12 months ago.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Cambridge, Massachusetts

• Biogen — Cambridge, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: US Biogen Clinical Trial Center

Conditions: Postpartum Depression