Can a new pill ease postpartum depression? a Real-World study investigates

NCT ID NCT07047820

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study follows adults in the United States who were prescribed zuranolone for postpartum depression (PPD) after giving birth. Researchers will track symptom changes using a standard questionnaire called the Edinburgh Postnatal Depression Scale (EPDS) at several time points, including 15 days after the first dose. The goal is to see whether symptoms improve in real-world settings, outside of controlled clinical trials. Participants will also report on breastfeeding, use of other medications, and their overall health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zuranolone
What this could lead to
If symptoms improve, this could support zuranolone as an effective real-world treatment for postpartum depression, helping new mothers recover faster.
What could go wrong
This is an observational study without a control group, so it cannot prove cause and effect. Results may be influenced by other factors, and not all participants may respond to the drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

305 people

The number who actually took part.

Started

Jun 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 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: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CVS Health

    Woonsocket, Rhode Island, 02895, United States

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