Post Partum DepressionPhase 3NCT03665038
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
A Phase 3 study testing Brexanolone in people with Post Partum Depression, run by Supernus Pharmaceuticals, Inc. at 17 sites in United States.
Trial summary
This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression (PPD). Read more about this study
- Who is it for?
- Ages 15 to 17 years, women only
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- Brexanolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 17 sitesUnited States
- Study dates
- 7 Sep 2018to 8 Jan 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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).
- Participant is ≤6 months postpartum at screening.
Who cannot join
- Active psychosis
- Attempted suicide during current episode of PPD
- Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Sage Investigational Site
Atlanta, Georgia, 30331
Sage Investigational Site
Chapel Hill, North Carolina, 27599
Sage Investigational Site
Decatur, Georgia, 30030
Sage Investigational Site
Edgewood, Kentucky, 41017
Sage Investigational Site
Flowood, Mississippi, 39232
Sage Investigational Site
Houston, Texas, 77058
Sage Investigational Site
Jackson, Mississippi, 39216
Sage Investigational Site
League City, Texas, 77573
Sage Investigational Site
Middleburg Heights, Ohio, 44130
Sage Investigational Site
Miramar, Florida, 33029
Sage Investigational Site
North Little Rock, Arkansas, 72758
Sage Investigational Site
Orlando, Florida, 32807
Sage Investigational Site
Owensboro, Kentucky, 42303
Sage Investigational Site
Pensacola, Florida, 32502
Sage Investigational Site
Pinellas Park, Florida, 33782
Sage Investigational Site
Pompano Beach, Florida, 33060
Sage Investigational Site
Tempe, Arizona, 85226
About this study
Official title: A Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression
This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression (PPD).
- Conditions
- Post Partum Depression
- Being tested
- Brexanolone
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrexanoloneDrug
Administered as IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Brexanolone | Experimental | Participants will receive a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study. Receives: Drug: Brexanolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.
Measured: From first dose of study drug up to end of follow-up period (up to Day 30)
Secondary outcomes (9)
Area Under the Concentration-Time Curve (AUC) From Time Zero to 60 Hours (AUC0-60)
Measured: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
AUC From Time Zero to Infinity (AUCinf)
Measured: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Maximum (Peak) Plasma Concentration (Cmax)
Measured: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Time at Maximum (Peak) Plasma Concentration (Tmax)
Measured: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Steady-State Drug Concentration in the Plasma During Constant-Rate Infusion (Css)
Given that brexanolone is infused to steady-state plasma concentrations, the model-predicted steady-state drug concentration in the plasma during constant-rate infusion value also represents the predicted maximum plasma concentration at the highest infused dose (90 ug/kg/h).
Measured: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg)
Cavg was evaluated as the time-weighted average plasma concentrations of brexanolone over the interval.
Measured: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Half-Life of First Elimination Phase of Brexanolone (Thalf)
Half-life is the time required for half of the drug to be eliminated from the serum.
Measured: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Clearance of Brexanolone (CL/F)
Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.
Measured: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Steady-State of Volume of Distribution (Vss)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Measured: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start7 Sep 2018
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665038
- Sponsor's protocol ID
- 547-PPD-304
- Other IDs
- 2017-004356-34, 2017
- Status last verified
- Jul 2022
- First submitted
- 30 Apr 2018
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression
- ClinicalTrials.gov ID
- NCT03665038
- Acronym / sponsor ID
- 547-PPD-304
- Conditions
- Post Partum Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Posted 11 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of brexanolone in the treatment of adolescent female participants with postpartum depression (PPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brexanolone | Experimental | Drug: BrexanoloneParticipants will receive a 60-hour single continuous IV infusion of brexanolone, at 30 mcg/kg/hour (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
- Participant is ≤6 months postpartum at screening.
Key exclusion criteria (4 listed)
- Active psychosis
- Attempted suicide during current episode of PPD
- Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrexanoloneAdministered as IV infusion. | Drug | Brexanolone |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to end of follow-up period (up to Day 30)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.
9 secondary outcomes
Area Under the Concentration-Time Curve (AUC) From Time Zero to 60 Hours (AUC0-60)
Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
AUC From Time Zero to Infinity (AUCinf)
Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Maximum (Peak) Plasma Concentration (Cmax)
Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Time at Maximum (Peak) Plasma Concentration (Tmax)
Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Steady-State Drug Concentration in the Plasma During Constant-Rate Infusion (Css)
Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg)
Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Half-Life of First Elimination Phase of Brexanolone (Thalf)
Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Clearance of Brexanolone (CL/F)
Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Steady-State of Volume of Distribution (Vss)
Time frame: Day 1: From 0 hour (pre-infusion) and at 4, 8, 12, 24, 30, 36, 48 hours during the infusion; at 60 hours (end of infusion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brexanolone in people with Post Partum Depression, run by Supernus Pharmaceuticals, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug up to end of follow-up period (up to Day 30)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.