A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03665038 |
Recruitment Status :
Completed
First Posted : September 11, 2018
Last Update Posted : February 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Post Partum Depression | Drug: Brexanolone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | May 17, 2018 |
Actual Primary Completion Date : | January 8, 2021 |
Actual Study Completion Date : | January 8, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Brexanolone |
Drug: Brexanolone
Brexanolone |
- Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 days ]An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE is an AE that occurs after the first administration of a study drug.
- Area Under the Concentration-time Curve (AUC) from Time Zero to 60 Hours (AUC0-60) [ Time Frame: 3 days ]
- AUC from Time Zero to Infinity (AUC∞) [ Time Frame: 3 days ]
- Maximum (Peak) Plasma Concentration (Cmax) [ Time Frame: 3 days ]
- Time at Maximum (Peak) Plasma Concentration (tmax) [ Time Frame: 3 days ]
- Steady-state Drug Concentration in Plasma During Constant-rate Infusion (Css) [ Time Frame: 3 days ]
- Average Drug Concentration in Plasma at Steady State During a Dosing Interval (Cavg) [ Time Frame: 3 days ]

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Ages Eligible for Study: | 15 Years to 17 Years (Child) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- 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 DSM-5 Disorders (SCID-5).
- Participant is ≤6 months postpartum at screening.
Key Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665038
United States, Arizona | |
Sage Investigational Site | |
Tempe, Arizona, United States, 85226 | |
United States, Arkansas | |
Sage Investigational Site | |
North Little Rock, Arkansas, United States, 72758 | |
United States, Florida | |
Sage Investigational Site | |
Miramar, Florida, United States, 33029 | |
Sage Investigational Site | |
Orlando, Florida, United States, 32807 | |
Sage Investigational Site | |
Pensacola, Florida, United States, 32502 | |
Sage Investigational Site | |
Pinellas Park, Florida, United States, 33782 | |
Sage Investigational Site | |
Pompano Beach, Florida, United States, 33060 | |
United States, Georgia | |
Sage Investigational Site | |
Atlanta, Georgia, United States, 30331 | |
Sage Investigational Site | |
Decatur, Georgia, United States, 30030 | |
United States, Kentucky | |
Sage Investigational Site | |
Edgewood, Kentucky, United States, 41017 | |
Sage Investigational Site | |
Owensboro, Kentucky, United States, 42303 | |
United States, Mississippi | |
Sage Investigational Site | |
Flowood, Mississippi, United States, 39232 | |
Sage Investigational Site | |
Jackson, Mississippi, United States, 39216 | |
United States, North Carolina | |
Sage Investigational Site | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Ohio | |
Sage Investigational Site | |
Middleburg Heights, Ohio, United States, 44130 | |
United States, Texas | |
Sage Investigational Site | |
Houston, Texas, United States, 77058 | |
Sage Investigational Site | |
League City, Texas, United States, 77573 |
Responsible Party: | Sage Therapeutics |
ClinicalTrials.gov Identifier: | NCT03665038 |
Other Study ID Numbers: |
547-PPD-304 2017-004356-34 ( EudraCT Number ) |
First Posted: | September 11, 2018 Key Record Dates |
Last Update Posted: | February 9, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data sharing will be consistent with the results submission policy of ClinicalTrials.gov. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Depression, Postpartum Depression Depressive Disorder Behavioral Symptoms |
Mood Disorders Mental Disorders Puerperal Disorders Pregnancy Complications |