Recruiting

Zuranolone

Sponsor:

Biogen

Code:

NCT07398469

Conditions

Postpartum Depression

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zuranolone

Study Details

Brief summary:

In this study, researchers will learn how postpartum depression symptoms may change after people first start taking zuranolone. This is a drug available for doctors to prescribe for people with postpartum depression, also known as PPD. After giving birth, people with PPD can suffer from symptoms like tiredness, sadness, and a loss of interest in their daily activities.

This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will be found in the United States using a database from Accredo Specialty Pharmacy. This will include anyone who has a new prescription for zuranolone and were pregnant in the last 12 months before joining the study.

The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be done using a questionnaire called the Edinburgh Postnatal Depression Scale, also known as the EPDS.

The main question that researchers want to answer is:

• Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15?

Researchers will also learn about :

  • Changes in participants' EPDS scores at Day 3, Day 45 and Day 90 in the study
  • Changes in EPDS scores at Day 3, Day 15, Day 45, and Day 90 in a group of participants who have moderately severe PPD before starting zuranolone
  • How many participants breastfeed their babies while taking zuranolone
  • How many participants report not starting new medicine after finishing their zuranolone treatment

The study will be done as follows:

  • People with PPD who get a new zuranolone prescription through Accredo Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study.
  • Before taking their first dose of zuranolone, participants will be asked to answer written questions about their symptoms using the online EPDS survey. 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 survey, 15 days, 45 days, and 90 days after taking the first dose of zuranolone. Some participants will also be asked to complete a survey about 3 days after starting treatment. Each survey will take about 10-15 minutes to finish.

Conditions

Postpartum Depression

Study ID

NCT07398469

Start date

Dec 22, 2025

Status verified date

Sep, 2026

Completion date

Mar 29, 2027

Anticipated

Primary completion date

Mar 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Participants who are prescribed zuranolone for PPD will be invited to an online survey to evaluate changes in EPDS score on Days 0, 15, 45 and 90.

Cohort 2

Participants who are prescribed zuranolone for PPD will be invited to an online survey to evaluate changes in EPDS score on Days 0, 3, 15, 45 and 90.

Interventions

Zuranolone

Administered orally

Primary outcome measure

  • Change From Baseline in the Edinburgh Postnatal Depression Scale (EPDS) Score at Day 15 [ Time Frame: Baseline (Day 0), Day 15 ]

Central Contacts and Locations

Central contacts

US Biogen Clinical Trial Center

866-633-4636clinicaltrials@biogen.com

Global Biogen Clinical Trial Center

clinicaltrials@biogen.com

Locations

Biogen

Recruiting

Cambridge, Massachusetts, United States, 02142

Principal Investigator:

Kebede Beyene

More Information

Sponsor

Biogen

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Biogen on 2026-09-08.