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).

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

Post Partum Depression

Brexanolone

A Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Brexanolone in the Treatment of Adolescent Female Subjects With Postpartum Depression

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.

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).

Cavg was evaluated as the time-weighted average plasma concentrations of brexanolone over
the interval.

Half-life is the time required for half of the drug to be eliminated from the serum.

Clearance is defined as the volume of plasma from which a substance is completely removed
per unit time.

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.

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.

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).

Sage Investigational Site

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.

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).

Cavg was evaluated as the time-weighted average plasma concentrations of brexanolone over the interval.

Clearance is defined as the volume of plasma from which a substance is completely removed per unit time.

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.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the Participation Requirements?

View clinical trial results on registries

Locations

Location

Status