What is zuranolone studying for postpartum depression?

Zuranolone is being studied to understand how it affects symptoms of postpartum depression using patient surveys called the Edinburgh Postnatal Depression Scale. Researchers want to learn how symptoms change after starting this treatment. The study is sponsored by Biogen and involves people recently prescribed zuranolone.

Who may be eligible for this postpartum depression clinical trial?

Adults 18 years or older who are female, have a confirmed diagnosis of postpartum depression, and have been pregnant within the last 12 months may be eligible. Participants must have a new prescription for zuranolone and be able to complete surveys in English. Please review eligibility criteria for more details.

Is there any cost to participate in this postpartum depression clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Age: 18Years +

FEMALE

ID07398469

Study of Changes in Postpartum Depression Symptoms Over Time in Women Starting Zuranolone Treatment

Led by Biogen · Updated on 2026-02-10

200

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying how symptoms of postpartum depression PPD change in people starting treatment with zuranolone, a drug prescribed for PPD. This observational study collects health information without altering medical care, focusing on people in the United States who have a new prescription for zuranolone and were pregnant within the last 12 months. The main goal is to understand changes in depression symptoms using the Edinburgh Postnatal Depression Scale EPDS. Participants who receive a zuranolone prescription through Accredo Specialty Pharmacy will be invited to join the study. Before their first dose, they will complete online surveys about their symptoms and background. They must start taking zuranolone within 7 days of joining. Follow-up surveys using the EPDS will take place at days 15, 45, and 90 after starting the medication to track symptom changes and other factors like breastfeeding and medication use. Participants will provide information through multiple online surveys, each taking about 10 to 15 minutes. Researchers will assess changes in EPDS scores at several time points, breastfeeding status during treatment, and medication usage after zuranolone completion. The study aims to gather detailed, patient-reported data over a 90-day period without changing participants usual medical care.

CONDITIONS

Brief Title

A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone

Who Can Participate

Age: 18Years +

FEMALE

Eligibility Criteria

You may qualify if you...

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

You will not qualify if you...

Prior fill of zuranolone or brexanolone in last 12 months.
Participants who have taken one or more doses of zuranolone at 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.

Research Team

US Biogen Clinical Trial Center

Global Biogen Clinical Trial Center

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