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New study: postpartum depression treatment may soon be available at home

NCT ID NCT05059600

Symptom relief Sponsor: Supernus Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether the drug ZULRESSO (brexanolone) can be safely given to women with postpartum depression in their own homes instead of a hospital. Fifty-two women took part. The main goal was to see if any side effects caused the infusion to be stopped or interrupted. The results help show whether home treatment is a safe option.

What this could mean

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

Active substance
Brexanolone (ZULRESSO), a synthetic version of the hormone allopregnanolone, given as an intravenous infusion
What this could lead to
If successful, this could allow women with postpartum depression to receive treatment in the comfort of their own home instead of a hospital.
What could go wrong
This is a small, completed phase 4 study focused on safety and feasibility, not on how well the drug works. Home administration may still carry risks like infusion reactions or need for medical backup.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

52 people

The number who actually took part.

Started

Oct 2021

Finished

Jul 2022

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.

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.

Inclusion Criteria: 1. Ambulatory female ≥18 years of age. 2. Participant has a current diagnosis of postpartum depression (PPD), as confirmed by the investigator. 3. Participant agrees not to be the primary caregiver of any dependents during the infusion and must be accompanied by another adult (other than the home healthcare provider) during interactions with their child(ren). 4. Participant has no history of sleep apnea or any clinically significant respiratory conditions. 5. Participant agrees to refrain from the use of central nervous system depressants, such as opioids, benzodiazepines, sleep aids and from drinking alcohol during the infusion. 6. Participant is suitable for administration of ZULRESSO® in a home setting, as per the judgement of the investigator. 7. Participant's home is suitable and has necessary provisions for administration of ZULRESSO® and meets the following criteria: * safe environment for the home infusion provider staff. * access to a working telephone. * electricity and grounded electrical outlets. * running water. * access to back-up emergency services (911 service or ambulance availability). * sanitary environment. 8. Participant agrees to stay at home until the end-of-study visit has been completed, except for a medical emergency. 9. Participant must have a negative pregnancy test at screening and on Day 1 prior to the start of the ZULRESSO® infusion. Exclusion Criteria: 1. Participant has end stage renal failure. 2. Participant has known allergy to progesterone or allopregnanolone or any excipients in the brexanolone injection. 3. Participant is currently at risk of suicide, as judged by the investigator, or has attempted suicide associated with the current episode of PPD.

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Conditions

The condition(s) this trial relates to.

postpartum depression

As listed by the trial registrant

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

Postpartum depression

Contacts and locations

Locations

  • Sage Investigational Site

    Culver City, California, 90230, United States

  • Sage Investigational Site

    Miramar, Florida, 33029, United States

  • Sage Investigational Site

    Pompano Beach, Florida, 33060, United States

  • Sage Investigational Site

    New York, New York, 10036, United States

  • Sage Investigational Site

    League City, Texas, 77573, United States

  • Virtual Site (recruiting nationwide)

    Culver City, California, 90230, United States

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