New IV drug shows promise for severe Post-Birth depression
NCT ID NCT02614547
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested an experimental drug called SAGE-547, given as an IV infusion, in 21 adult women with severe postpartum depression. The goal was to see if it could quickly reduce depression symptoms compared to a placebo. The trial was randomized and double-blind, meaning neither patients nor doctors knew who got the real drug.
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 (a drug given as an IV infusion)
- What this could lead to
- If it works, this could offer a fast-acting treatment option for women with severe postpartum depression, potentially easing symptoms within days.
- What could go wrong
- This is a small, early-phase trial with only 21 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
21 people
The number who actually took part.
- Started
-
Dec 2015
- Finished
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Jun 2016
- 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
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Female participants only
- Healthy volunteers
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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 Hide 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: * Participant either must have ceased lactating at Screening; or if still lactating at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug. * Participant 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 was less than or equal to (\<=) six months postpartum. * Participant must be amenable to intravenous therapy. Key Exclusion Criteria: * Active psychosis. * Attempted suicide associated with index case of postpartum depression. * Medical history of seizures. * Medical history of bipolar disorder. Note: suicidal ideation was not an exclusion. 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
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Sage Investigational Site
Atlanta, Georgia, 30342, United States
-
Sage Investigational Site
Worcester, Massachusetts, 01655, United States
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Sage Investigational Site
Chapel Hill, North Carolina, 27514, United States
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Sage Investigational Site
Philadelphia, Pennsylvania, 19104, United States