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New drug ZULRESSO offers hope for moms with postpartum depression

NCT ID NCT03924492

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This program provides early access to ZULRESSO (brexanolone) for adult women with postpartum depression before the drug is widely available. Eligible women receive a one-time injection under medical supervision. The goal is to help ease severe depression symptoms quickly.

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) injection
What this could lead to
If successful, this program could provide a new treatment option for women with postpartum depression, potentially easing severe symptoms quickly.
What could go wrong
This is an expanded access program, not a controlled trial, so results may not be generalizable. Risks include side effects like sedation or sudden loss of consciousness.

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.

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

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. Subject has signed an informed consent form prior to any study-specific procedures being performed 2. Subject is an ambulatory female at least 18 years of age 3. Subject agrees to adhere to the study requirements 4. Subject agrees not to be the primary caregiver of any dependents during the infusion 5. Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion 6. Subject has a current diagnosis of PPD, as assessed by the Investigator Exclusion Criteria: 1. Subject has end stage renal disease 2. Subject has a known allergy to progesterone or allopregnanolone

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.