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

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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
11
sites
Saint Louis, Missouri 63110
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Saint Louis, MO
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Austin, Texas 78723
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Austin, TX
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Decatur, Georgia 30030
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Decatur, GA
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Garden Grove, California 92845
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Garden Grove, CA
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Jacksonville, Florida 32209
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Jacksonville, FL
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Lauderhill, Florida 33319
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Lauderhill, FL
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Lemon Grove, California 91945
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Lemon Grove, CA
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Little Rock, Arkansas 27702
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Little Rock, AR
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Orange, California 92868
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Orange, CA
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Orlando, Florida 32803
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Orlando, FL
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Richardson, Texas 75080
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Richardson, TX
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