NCT03692910

A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode

A 2-Part Study (Open-label Followed by Double-blind, Randomized, Placebo-controlled, Parallel Group) of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in the Treatment of Subjects With Bipolar I/II Disorder With a Current Major Depressive Episode

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a current major depressive episode.

Detailed description

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

Conditions

• Bipolar Disorder I
• Bipolar Disorder II
• Major Depressive Episode

Interventions

Type	Name	Description
DRUG	SAGE-217	SAGE-217 capsule
DRUG	Placebo	SAGE-217 matching placebo capsule

Timeline

• Start date: 2018-08-23
• Primary completion: 2019-05-21
• Completion: 2019-05-21
• First posted: 2018-10-02
• Last updated: 2023-12-13
• Results posted: 2022-04-20

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study