A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)

Post Partum Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665038
• Other study ID #: 547-PPD-304
• Secondary ID: 2017-004356-34
• Status: Completed
• Phase: Phase 3
• Start date: September 7, 2018
• Est. completion date: January 8, 2021

Study information

• Verified date: July 2022
• Source: Sage Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 8, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 17 Years

Eligibility

Key Inclusion Criteria:

1. 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).

2. Participant is =6 months postpartum at screening.

Key Exclusion Criteria:

1. Active psychosis

2. Attempted suicide during current episode of PPD

3. Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post Partum Depression

Intervention

Drug:
• Brexanolone
Administered as IV infusion.

Locations

Country	Name	City	State
United States	Sage Investigational Site	Atlanta	Georgia
United States	Sage Investigational Site	Chapel Hill	North Carolina
United States	Sage Investigational Site	Decatur	Georgia
United States	Sage Investigational Site	Edgewood	Kentucky
United States	Sage Investigational Site	Flowood	Mississippi
United States	Sage Investigational Site	Houston	Texas
United States	Sage Investigational Site	Jackson	Mississippi
United States	Sage Investigational Site	League City	Texas
United States	Sage Investigational Site	Middleburg Heights	Ohio
United States	Sage Investigational Site	Miramar	Florida
United States	Sage Investigational Site	North Little Rock	Arkansas
United States	Sage Investigational Site	Orlando	Florida
United States	Sage Investigational Site	Owensboro	Kentucky
United States	Sage Investigational Site	Pensacola	Florida
United States	Sage Investigational Site	Pinellas Park	Florida
United States	Sage Investigational Site	Pompano Beach	Florida
United States	Sage Investigational Site	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Sage Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first dose of study drug up to end of follow-up period (up to Day 30)
Secondary	Area Under the Concentration-Time Curve (AUC) From Time Zero to 60 Hours (AUC0-60)		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)
Secondary	AUC From Time Zero to Infinity (AUCinf)		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)
Secondary	Maximum (Peak) Plasma Concentration (Cmax)		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)
Secondary	Time at Maximum (Peak) Plasma Concentration (Tmax)		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)
Secondary	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).	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)
Secondary	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.	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)
Secondary	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.	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)
Secondary	Clearance of Brexanolone (CL/F)	Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.	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)
Secondary	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.	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)

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