Overview

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

Status:
Completed
Trial end date:
2019-03-23
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sage Therapeutics
Criteria
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.