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New injection shows promise for postpartum depression

NCT ID NCT02942004

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called SAGE-547 (brexanolone) given as a 60-hour intravenous infusion to 138 women with severe or moderate postpartum depression. The goal was to see if it could quickly reduce depressive symptoms compared to a placebo. Results showed that the drug significantly improved depression scores within days, offering a potential new option for new mothers struggling with this condition.

What this could mean

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

Active substance
SAGE-547 (brexanolone) injection
What this could lead to
If successful, this could provide a fast-acting treatment option for women suffering from postpartum depression, reducing symptoms within days.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all women. Side effects and individual responses vary, and the drug requires intravenous infusion in a medical setting.

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

138 people

The number who actually took part.

Started

Aug 2016

Finished

Oct 2017

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 to 45 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: * Participants must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s) from just prior to receiving study drug through nine days (Day 12) after the end of the infusion * Participants 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 DSM-IV Axis I Disorders (SCID-I) * Participant had a HAM-D total score of ≥26 at screening and Day 1 (prior to dosing) * Participant was ≤6 months postpartum at screening * Participant was amenable to IV therapy Key Exclusion Criteria: * Active psychosis * Attempted suicide associated with index case of postpartum depression * Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder. Note: Other protocol-defined inclusion/exclusion criteria applied.

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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

    Chandler, Arizona, 85226, United States

  • Sage Investigational Site

    Rogers, Arkansas, 72758, United States

  • Sage Investigational Site

    Lemon Grove, California, 91945, United States

  • Sage Investigational Site

    Orange, California, 92868, United States

  • Sage Investigational Site

    Ventura, California, 93003, United States

  • Sage Investigational Site

    Gainesville, Florida, 32607, United States

  • Sage Investigational Site

    Miami, Florida, 33147, United States

  • Sage Investigational Site

    Miramar, Florida, 33027, 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

    Atlanta, Georgia, 30331, United States

  • Sage Investigational Site

    Hoffman Estates, Illinois, 60169, United States

  • Sage Investigational Site

    Wichita, Kansas, 67226, United States

  • Sage Investigational Site

    Edgewood, Kentucky, 41017, United States

  • Sage Investigational Site

    Owensboro, Kentucky, 42303, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02114, United States

  • Sage Investigational Site

    Boston, Massachusetts, 02115, United States

  • Sage Investigational Site

    Flowood, Mississippi, 39232, United States

  • Sage Investigational Site

    Marlton, New Jersey, 08053, United States

  • Sage Investigational Site

    Glen Oaks, New York, 11004, United States

  • Sage Investigational Site

    Chapel Hill, North Carolina, 27514, United States

  • Sage Investigational Site

    Charlotte, North Carolina, 28211, United States

  • Sage Investigational Site

    Raleigh, North Carolina, 27612, United States

  • Sage Investigational Site

    Columbus, Ohio, 43210, United States

  • Sage Investigational Site

    Dayton, Ohio, 45417, United States

  • Sage Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • Sage Investigational Site

    Houston, Texas, 77030, United States

  • Sage Investigational Site

    Houston, Texas, 77058, United States

  • Sage Investigational Site

    Richardson, Texas, 75080, United States

  • Sage Investigational Site

    San Antonio, Texas, 78229, United States

  • Sage Investigational Site

    Orem, Utah, 84058, United States

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