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.
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
11
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials