A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-15

Study Completion Date

2016-06-22

Brief Summary

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This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression.

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Detailed Description

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Conditions

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Severe Postpartum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Participants received infusion rates of placebo matched to SAGE-547.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered as intravenous infusion.

SAGE-547

Participants received a 4-hour dose titration of 30 micrograms per kilogram per hour (micrograms/kg/hr) (0 to 4 hours), then 60 micrograms/kg/hr (4 to 24 hours), then 90 micrograms/kg/hr (24 to 52 hours), followed by a taper to 60 micrograms/kg/hr (52 to 56 hours), and 30 micrograms/kg/hr (56 to 60 hours).

Group Type EXPERIMENTAL

SAGE-547

Intervention Type DRUG

Administered as intravenous infusion.

Interventions

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SAGE-547

Administered as intravenous infusion.

Intervention Type DRUG

Placebo

Administered as intravenous infusion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant either must have ceased lactating at Screening; or if still lactating at Screening, must have already fully and permanently weaned their infant(s) from breastmilk; or if still actively breastfeeding at Screening, must agree to cease giving breastmilk to their infant(s) prior to receiving study drug.
* Participant 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-IV Axis I Disorders (SCID-I).
* Participant was less than or equal to (\<=) six months postpartum.
* Participant must be amenable to intravenous therapy.

Exclusion Criteria

* Active psychosis.
* Attempted suicide associated with index case of postpartum depression.
* Medical history of seizures.
* Medical history of bipolar disorder.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No