NCT02978326

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Biogen · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Conditions

• Postpartum Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-01-04
• Primary completion: 2018-11-15
• Completion: 2018-12-11
• First posted: 2016-11-30
• Last updated: 2023-12-15
• Results posted: 2021-12-16

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study