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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-217 in the Treatment of Adult Female Subjects With Severe Postpartum Depression
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).
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Age
18 - 45 years
Sex
FEMALE
Healthy Volunteers
No
Sage Investigational Site
Little Rock, Arkansas, United States
Sage Investigational Site
Beverly Hills, California, United States
Sage Investigational Site
Oceanside, California, United States
Sage Investigational Site
Wildomar, California, United States
Sage Investigational Site
Washington D.C., District of Columbia, United States
Sage Investigational Site
Aventura, Florida, United States
Sage Investigational Site
Miami, Florida, United States
Sage Investigational Site
Orlando, Florida, United States
Sage Investigational Site
Pensacola, Florida, United States
Sage Investigational SIte
Pinellas Park, Florida, United States
Start Date
January 4, 2017
Primary Completion Date
November 15, 2018
Completion Date
December 11, 2018
Last Updated
December 15, 2023
276
ACTUAL participants
SAGE-217 15/20 mg Oral Solution
DRUG
Placebo
DRUG
SAGE 217 30 mg Capsules
DRUG
Lead Sponsor
Biogen
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05585164