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

Status:	Recruiting
Conditions:	Depression, Depression, Major Depression Disorder (MDD), Psychiatric
Therapuetic Areas:	Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	18 - 65
Updated:	3/6/2019
Start Date:	August 19, 2018
End Date:	September 2019
Contact:	Jasmine Alhassani
Email:	Jasmine.Alhassani@sagerx.com
Phone:	617-949-4279

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

This is an open-label study evaluating 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.

This posting addresses Part A

Inclusion Criteria:

1. Subject has a documented history of hypomanic or manic episode and a diagnosis of
bipolar I or bipolar II disorder with a current major depressive episode.

Exclusion Criteria:

1. Subject has a history of suicide attempt.

2. Subject has current suicidal ideation with plans.

3. Subject has a history of rapid cycling bipolar disorder.

We found this trial at

sites

Sage Investigational Site

Orange, California 92868

from

Orange, CA