drugset / Trial / NCT03692910

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

NCT03692910

Phase 2 Completed 35 enrolled Biogen
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-08-23
Primary completion
2019-05-21
Completion
2019-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Zuranolone Small molecule 30 mg Oral