The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional treatment with either lithium or valproate, which are already FDA (Food and Drug Administration)-approved treatments for mania.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
343
Mean reduction in manic episodes and major depressive episodes from baseline to endpoint (week 6).
Major improvement in anxiety and depression from baseline to endpoint (week 6)
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Investigational Site
La Palma, California, United States
Investigational Site
Kansas City, Kansas, United States
Investigational Site
Shreveport, Louisiana, United States
Investigational Site
Somerville, Massachusetts, United States
Investigational Site
Farmington Hills, Michigan, United States
Investigational Site
Staten Island, New York, United States
Investigational Site
Madison, Tennessee, United States
Investigational Site
Bellaire, Texas, United States
Investigational Site
Dallas, Texas, United States
Investigational Site
Bellevue, Washington, United States
...and 34 more locations