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A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression

NCT02978326 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2023-12-15

Study results available
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Summary

The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).

Conditions

Interventions

DRUG

SAGE-217 15/20 mg Oral Solution

SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).

DRUG

Placebo

SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.

DRUG

SAGE 217 30 mg Capsules

SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2018-11-15
Completion
2018-12-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02978326 on ClinicalTrials.gov