A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
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| ClinicalTrials.gov Identifier: NCT03665038 |
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Recruitment Status :
Completed
First Posted : September 11, 2018
Results First Posted : August 11, 2022
Last Update Posted : August 11, 2022
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Sponsor:
Sage Therapeutics
Information provided by (Responsible Party):
Sage Therapeutics
- Study Details
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- Disclaimer
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post Partum Depression | Drug: Brexanolone | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 28 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 : | September 7, 2018 |
| Actual Primary Completion Date : | January 8, 2021 |
| Actual Study Completion Date : | January 8, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Depression
MedlinePlus related topics:
Postpartum Depression
Drug Information available for:
Brexanolone
| Arm | Intervention/treatment |
|---|---|
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Experimental: Brexanolone
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.
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Drug: Brexanolone
Administered as IV infusion. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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) ]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).
- 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) ]Cavg was evaluated as the time-weighted average plasma concentrations of brexanolone over the interval.
- 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) ]Half-life is the time required for half of the drug to be eliminated from the serum.
- 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) ]Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.
- 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) ]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.
Information from the National Library of Medicine
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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 |
Criteria
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 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Axis I 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.
Information from the National Library of Medicine
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
Locations
| 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 | |
Sponsors and Collaborators
Sage Therapeutics
Study Documents (Full-Text)
Documents provided by Sage Therapeutics:
Documents provided by Sage Therapeutics:
Study Protocol [PDF] December 20, 2019
Statistical Analysis Plan [PDF] March 10, 2021
Additional Information:
| 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 |
| Results First Posted: | August 11, 2022 |
| Last Update Posted: | August 11, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
Additional relevant MeSH terms:
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Depression, Postpartum Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Puerperal Disorders Pregnancy Complications |
Brexanolone Neurosteroids Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs GABA Modulators GABA Agents |