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New hope for teen moms: drug targets postpartum depression

NCT ID NCT03665038

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 the safety of a drug called brexanolone in 28 teenage mothers with postpartum depression. The drug was given as an IV infusion. Researchers monitored side effects and how the drug moved through the body. The goal was to see if it could be a safe treatment option for this age group.

What this could mean

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

Active substance
brexanolone (given as an IV infusion)
What this could lead to
If it works, this could provide a treatment option for teenage mothers with postpartum depression.
What could go wrong
This was a small, open-label study with no placebo group, so results are preliminary. Side effects are possible, and it may not work for everyone.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

28 people

The number who actually took part.

Started

Sep 2018

Finished

Jan 2021

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

15 to 17 years

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: 1. Participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Axis I Disorders (SCID-5). 2. Participant is ≤6 months postpartum at screening. Key Exclusion Criteria: 1. Active psychosis 2. Attempted suicide during current episode of PPD 3. Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder. Note: Other protocol-defined inclusion/exclusion criteria may apply.

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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.

Post partum depression

Contacts and locations

Locations

  • Sage Investigational Site

    Tempe, Arizona, 85226, United States

  • Sage Investigational Site

    North Little Rock, Arkansas, 72758, United States

  • Sage Investigational Site

    Miramar, Florida, 33029, United States

  • Sage Investigational Site

    Orlando, Florida, 32807, United States

  • Sage Investigational Site

    Pensacola, Florida, 32502, United States

  • Sage Investigational Site

    Pinellas Park, Florida, 33782, United States

  • Sage Investigational Site

    Pompano Beach, Florida, 33060, United States

  • Sage Investigational Site

    Atlanta, Georgia, 30331, United States

  • Sage Investigational Site

    Decatur, Georgia, 30030, United States

  • Sage Investigational Site

    Edgewood, Kentucky, 41017, United States

  • Sage Investigational Site

    Owensboro, Kentucky, 42303, United States

  • Sage Investigational Site

    Flowood, Mississippi, 39232, United States

  • Sage Investigational Site

    Jackson, Mississippi, 39216, United States

  • Sage Investigational Site

    Chapel Hill, North Carolina, 27599, United States

  • Sage Investigational Site

    Middleburg Heights, Ohio, 44130, United States

  • Sage Investigational Site

    Houston, Texas, 77058, United States

  • Sage Investigational Site

    League City, Texas, 77573, United States

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