Depression

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

Recruiting · Woonsocket, Rhode Island

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What is this study?

It is , overseen by an independent and licensed medical staff.

Read the full clinical description

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 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 45, 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 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, 15 days and 45 days after taking the first dose of zuranolone.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

•Adults in the United States who were prescribed zuranolone for PPD and had one successful fill within 12 months after their pregnancy ended (between June 2025 and May 2026)
•People who can live in the U.S. during the study
•People who can complete the questionnaires on their own
•People who had not taken too much zuranolone at screening (only the allowed dosing situation described by the study)
•People who can take their first zuranolone dose within 7 days of joining the study

🚫 You may not be able to join if…

•People who had a fill of zuranolone or brexanolone within the last 12 months
•People who have 2 or more doses of zuranolone at the time of screening
•People with a current or past bipolar disorder
•People who did not complete the baseline surveys before the 2nd dose of zuranolone
•People whose pregnancy ended more than 12 months ago

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

✓Adults roughly 18 and older

!Not for people who are pregnant or breastfeeding

What to expect, step by step

1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Source: ClinicalTrials.gov · NCT07047820 · Locations: Rhode Island