Postpartum DepressionNCT07398469
A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone
An observational study of Postpartum Depression, run by Biogen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Zuranolone
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2025to 29 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants prescribed zuranolone who consent to participate in this study and meet all of the inclusion criteria, none of the exclusion criteria, and complete baseline (Day 0) will be considered enrolled in this study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Global Biogen Clinical Trial Center contact
United States1 site, 1 recruiting
- Recruiting
Biogen
Cambridge, Massachusetts, 02142
Kebede Beyene
About this study
Official title: A Longitudinal Online Survey of Patient-Reported Changes in Postpartum Depression Symptoms Following Zuranolone Use
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.
Read more
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.
Read the detailed description
The primary objective of this study is to assess the reduction in Postpartum Depression (PPD) symptoms via the Edinburgh Postnatal Depression Scale (EPDS) at Day 15 in study participants. The secondary objectives are to assess the reduction in PPD symptoms via the EPDS at Day 3 (cohort 2 only), to assess the reduction in PPD symptoms via the EPDS at Day 45 and Day 90 in study participants, reduction in PPD symptoms via the EPDS at Day 15,Day 45, and Day 90 in a subgroup of participants with moderate PPD at baseline, to assess breastfeeding status during treatment with zuranolone as reported at Day 45 and to characterize treatment usage across the 90-day period via self-reported survey questions.
- Conditions
- Postpartum Depression
- Being tested
- Zuranolone
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZuranoloneDrug
Also called Zurzuvae, BIIB125
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Zuranolone | |
| 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. Receives: Drug: Zuranolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Edinburgh Postnatal Depression Scale (EPDS) Score at Day 15
EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms.
Measured: Baseline (Day 0), Day 15
Secondary outcomes (8)
Change From Baseline in the EPDS Score
EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms.
Measured: Baseline (Day 0), Days 3 (Cohort 2 only), 45 and 90
Change From Baseline in the EPDS Score in Participants With Moderate Severity
EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms.
Measured: Baseline (Day 0), Days 3 (Cohort 2 only), 15, 45 and 90
Change From Baseline in the EPDS by Baseline Severity
EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms.
Measured: Baseline up to Day 90
Number of Participants With no New Initiation of Medication After Completion of Zuranolone
This outcome measure will be self-reported by participants.
Measured: At Days 45 and 90
Number of Participants who Report no New Initiation of Treatment After Completion of Zuranolone by Severity
This outcome measure will be self-reported by participants.
Measured: At Days 45 and 90
Number of Participants Feeding Their Baby Breastmilk as Usual While Taking Zuranolone
This outcome measure will be self-reported by participants.
Measured: At Day 45
Number of Participants Achieving Remission
Measured: At Days 15, Day 45, and Day 90
Number of Participants Achieving Remission by Baseline Severity
Measured: At Days 15, Day 45, and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start22 Dec 2025
- Primary completion29 Mar 2027 (estimated)
- Study completion29 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398469
- Sponsor's protocol ID
- US-ZRN-12376
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Online Survey of Patient-Reported Changes in Postpartum Depression Symptoms Following Zuranolone Use
- ClinicalTrials.gov ID
- NCT07398469
- Acronym / sponsor ID
- US-ZRN-12376
- Conditions
- Postpartum Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 29 Mar 2027 (estimated)
- Study completion
- 29 Mar 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study is to assess the reduction in Postpartum Depression (PPD) symptoms via the Edinburgh Postnatal Depression Scale (EPDS) at Day 15 in study participants. The secondary objectives are to assess the reduction in PPD symptoms via the EPDS at Day 3 (cohort 2 only), to assess the reduction in PPD symptoms via the EPDS at Day 45 and Day 90 in study participants, reduction in PPD symptoms via the EPDS at Day 15,Day 45, and Day 90 in a subgroup of participants with moderate PPD at baseline, to assess breastfeeding status during treatment with zuranolone as reported at Day 45 and to characterize treatment usage across the 90-day period via self-reported survey questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: ZuranoloneParticipants 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 | – | Drug: ZuranoloneParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants prescribed zuranolone who consent to participate in this study and meet all of the inclusion criteria, none of the exclusion criteria, and complete baseline (Day 0) will be considered enrolled in this study.
Key inclusion criteria (4 listed)
- 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 (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZuranoloneAlso: Zurzuvae, BIIB125Administered orally | Drug | Cohort 1, Cohort 2 |
Primary outcome
Change From Baseline in the Edinburgh Postnatal Depression Scale (EPDS) Score at Day 15
Time frame: Baseline (Day 0), Day 15
EPDS is a 10-item self-report questionnaire used for the assessment of PPD symptoms. Each item is scored from 0-3, with a total score range of 0-30. Higher scores indicate more severe depressive symptoms.
8 secondary outcomes
Change From Baseline in the EPDS Score
Time frame: Baseline (Day 0), Days 3 (Cohort 2 only), 45 and 90
Change From Baseline in the EPDS Score in Participants With Moderate Severity
Time frame: Baseline (Day 0), Days 3 (Cohort 2 only), 15, 45 and 90
Change From Baseline in the EPDS by Baseline Severity
Time frame: Baseline up to Day 90
Number of Participants With no New Initiation of Medication After Completion of Zuranolone
Time frame: At Days 45 and 90
Number of Participants who Report no New Initiation of Treatment After Completion of Zuranolone by Severity
Time frame: At Days 45 and 90
Number of Participants Feeding Their Baby Breastmilk as Usual While Taking Zuranolone
Time frame: At Day 45
Number of Participants Achieving Remission
Time frame: At Days 15, Day 45, and Day 90
Number of Participants Achieving Remission by Baseline Severity
Time frame: At Days 15, Day 45, and Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Global Biogen Clinical Trial Center contact
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Depression, run by Biogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US Biogen Clinical Trial Center (866-633-4636, clinicaltrials@biogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Edinburgh Postnatal Depression Scale (EPDS) Score at Day 15 (time frame: Baseline (Day 0), Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.