Depression, PostpartumNCT07047820
A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancy
An observational study of Depression, Postpartum, run by Biogen at 1 site in United States.
Trial summary
In this study, researchers will learn more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Zuranolone
- How many people
- 305 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 2 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 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
- Adults who were prescribed and had one successful fill for zuranolone within 12 months following end of pregnancy for the treatment of PPD from March 2026 to July 2026 through CVS Specialty Pharmacy.
- Currently reside in the United States.
- Able to complete the questionnaires independently.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Observational Survey Study Assessing Effectiveness of Zuranolone in Improving PPD Symptoms in the Real-world Setting
In this study, researchers will learn more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD. After giving birth, adults with PPD can suffer from symptoms such as tiredness, sadness, and a loss of interest in their daily activities.
This study is known as an observational study, which means it collects health information about study participants after a healthcare professional has already prescribed treatment. Participants for this study will be found in the United States using a database from Consumer Value Store (CVS) Specialty Pharmacy. This will include anyone who was prescribed zuranolone between June 2025 and May 2026 and who filled the prescription within 1 year after the end of their pregnancy.
Read more
The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be measured using a questionnaire completed by participants called the Edinburgh Postnatal Depression Scale, also known as the EPDS. A higher score on the EPDS may indicate more severe PPD symptoms.
The main question researchers want to answer in this study is:
- Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15?
Researchers will also learn more about:
- Changes in participants' EPDS scores from before treatment to Day 3, Day 45, and Day 90, which is 30 days after treatment ends.
- How many participants breastfeed their babies while taking zuranolone
- How many participants do not start new medicine after finishing their zuranolone treatment
- How many participants take new medicines after finishing zuranolone
- How many participants already tried other medicines for their depression symptoms before joining this study
- How many participants take other medicines in general while taking zuranolone
- Characteristics of participants' treatment use during the study
This study will be done as follows:
- People who fill their zuranolone prescription through CVS Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study.
- Those who agree to take part will answer written questions about their symptoms using the EPDS tool. 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 tools, 3 days, 15 days, 45 days, and 90 days after taking the first dose of zuranolone.
Read the detailed description
The primary objective of this study is to assess the effectiveness of zuranolone in reducing postpartum depression (PPD) symptoms via the Edinburgh Postnatal Depression Scale (EPDS) at Day 15. The secondary objectives are to assess the effectiveness of zuranolone in reducing PPD symptoms via the EPDS at Day 3, Day 45 and Day 90, to assess changes in EPDS score at day 3 among participants initiating zuranolone prior to day 0 completion versus those initiating zuranolone after/same day as day 0 completion, to assess breastfeeding status during treatment with zuranolone at Day 45 and to characterize treatment usage across the 90-day period via self-reported survey questions.
- Conditions
- Depression, Postpartum
- 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 as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants who are prescribed zuranolone for PPD and are filling zuranolone through a CVS specialty pharmacy will be contacted through email or the call center for enrollment in the study. Participants will complete 3 study visits: Day 0, Day 15, and Day 45. Receives: Drug: Zuranolone | |
| Cohort 2 | Participants who are prescribed zuranolone for PPD and are filling zuranolone through a CVS specialty pharmacy will be contacted through email or the call center for enrollment in the study. Participants will complete 5 study visits: Day 0, Day 3, Day 15, Day 45, and Day 90. Receives: Drug: Zuranolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohorts 1 and 2: Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) 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)
Cohorts 1 and 2: Change From Baseline in 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 (Cohort 2 only)
Cohorts 1 and 2: Change From Baseline in EPDS in Participants With Moderate Postpartum Depression (PPD) Severity at Days 15 and 45
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 15 and 45
Cohorts 1 and 2: Change From Baseline in 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 (Day 0) up to Day 45 (Cohort 1, up to Day 90 (Cohort 2)
Cohorts 1 and 2: Number of Participants Achieving Remission
Measured: At Days 15, 45 and 90 (Cohort 2 only)
Cohort 2: Change From Baseline on the EPDS at Day 3 Among Participants Initiating Zuranolone Prior to Day 0 Completion
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), At Day 3
Cohort 2: Change From Baseline on the EPDS at Day 3 Among Participants Initiating Zuranolone After/Same day as Day 0 Completion
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), At Day 3
Cohorts 1 and 2: Percentage of Participants That Self-Report no New Initiation of Medication After Completion of Zuranolone
Measured: At Days 45 and 90 (Cohort 2 only)
Cohorts 1 and 2: Number of Participants That Self-Report Feeding Their Baby Breastmilk as Usual While Taking Zuranolone
Measured: Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start30 Jun 2025
- Primary completion2 Aug 2026
- Study completion2 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies 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
- 305 participants (actual)
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
- NCT07047820
- Sponsor's protocol ID
- US-ZRN-12349
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2025
- 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
- Prospective, Observational Survey Study Assessing Effectiveness of Zuranolone in Improving PPD Symptoms in the Real-world Setting
- ClinicalTrials.gov ID
- NCT07047820
- Acronym / sponsor ID
- US-ZRN-12349
- Conditions
- Depression, Postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 2 Aug 2026 (actual)
- Study completion
- 2 Aug 2026 (actual)
- First posted
- 2 Jul 2025 (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 more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD. After giving birth, adults with PPD can suffer from symptoms such as tiredness, sadness, and a loss of interest in their daily activities.
This study is known as an observational study, which means it collects health information about study participants after a healthcare professional has already prescribed treatment. Participants for this study will be found in the United States using a database from Consumer Value Store (CVS) Specialty Pharmacy. This will include anyone who was prescribed zuranolone between June 2025 and May 2026 and who filled the prescription within 1 year after the end of their pregnancy.
The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be measured using a questionnaire completed by participants called the Edinburgh Postnatal Depression Scale, also known as the EPDS. A higher score on the EPDS may indicate more severe PPD symptoms.
The main question researchers want to answer in this study is:
- Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15?
Researchers will also learn more about:
- Changes in participants' EPDS scores from before treatment to Day 3, Day 45, and Day 90, which is 30 days after treatment ends.
- How many participants breastfeed their babies while taking zuranolone
- How many participants do not start new medicine after finishing their zuranolone treatment
- How many participants take new medicines after finishing zuranolone
- How many participants already tried other medicines for their depression symptoms before joining this study
- How many participants take other medicines in general while taking zuranolone
- Characteristics of participants' treatment use during the study
This study will be done as follows:
- People who fill their zuranolone prescription through CVS Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study.
- Those who agree to take part will answer written questions about their symptoms using the EPDS tool. 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 tools, 3 days, 15 days, 45 days, and 90 days after taking the first dose of zuranolone.
Detailed description
The primary objective of this study is to assess the effectiveness of zuranolone in reducing postpartum depression (PPD) symptoms via the Edinburgh Postnatal Depression Scale (EPDS) at Day 15. The secondary objectives are to assess the effectiveness of zuranolone in reducing PPD symptoms via the EPDS at Day 3, Day 45 and Day 90, to assess changes in EPDS score at day 3 among participants initiating zuranolone prior to day 0 completion versus those initiating zuranolone after/same day as day 0 completion, to assess breastfeeding status during treatment with zuranolone 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 and are filling zuranolone through a CVS specialty pharmacy will be contacted through email or the call center for enrollment in the study. Participants will complete 3 study visits: Day 0, Day 15, and Day 45. |
| Cohort 2 | – | Drug: ZuranoloneParticipants who are prescribed zuranolone for PPD and are filling zuranolone through a CVS specialty pharmacy will be contacted through email or the call center for enrollment in the study. Participants will complete 5 study visits: Day 0, Day 3, Day 15, Day 45, and Day 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 the inclusion criteria, none of the exclusion criteria, and complete baseline (Day 0) will be considered enrolled in this study.
Key inclusion criteria (3 listed)
- Adults who were prescribed and had one successful fill for zuranolone within 12 months following end of pregnancy for the treatment of PPD from March 2026 to July 2026 through CVS Specialty Pharmacy.
- Currently reside in the United States.
- Able to complete the questionnaires independently.
Key exclusion criteria (6 listed)
- 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.
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 as specified in the treatment arm | Drug | Cohort 1, Cohort 2 |
Primary outcome
Cohorts 1 and 2: Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) 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
Cohorts 1 and 2: Change From Baseline in EPDS Score
Time frame: Baseline (Day 0), Days 3 (Cohort 2 only), 45 and 90 (Cohort 2 only)
Cohorts 1 and 2: Change From Baseline in EPDS in Participants With Moderate Postpartum Depression (PPD) Severity at Days 15 and 45
Time frame: Baseline (Day 0), Days 15 and 45
Cohorts 1 and 2: Change From Baseline in EPDS by Baseline Severity
Time frame: Baseline (Day 0) up to Day 45 (Cohort 1, up to Day 90 (Cohort 2)
Cohorts 1 and 2: Number of Participants Achieving Remission
Time frame: At Days 15, 45 and 90 (Cohort 2 only)
Cohort 2: Change From Baseline on the EPDS at Day 3 Among Participants Initiating Zuranolone Prior to Day 0 Completion
Time frame: Baseline (Day 0), At Day 3
Cohort 2: Change From Baseline on the EPDS at Day 3 Among Participants Initiating Zuranolone After/Same day as Day 0 Completion
Time frame: Baseline (Day 0), At Day 3
Cohorts 1 and 2: Percentage of Participants That Self-Report no New Initiation of Medication After Completion of Zuranolone
Time frame: At Days 45 and 90 (Cohort 2 only)
Cohorts 1 and 2: Number of Participants That Self-Report Feeding Their Baby Breastmilk as Usual While Taking Zuranolone
Time frame: Day 45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. This study is not recruiting at the moment.
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 Depression, Postpartum, 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 3 inclusion and 6 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohorts 1 and 2: Change From Baseline in Edinburgh Postnatal Depression Scale (EPDS) 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.