Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder
A Phase IIIb, Randomized, Double-Blind, Parallel Group Study in Bipolar I Patients to Assess the Efficacy and Safety of SPD417 Administered Once Daily vs Twice Daily in the Treatment of Manic Symptoms
Lead SponsorValidus Pharmaceuticals
StatusCompleted No Results Posted
The purpose of this study is to compare the efficacy and safety of SPD417 in treating bipolar manic symptoms, when given once daily in the evening vs. twice daily.
Inclusion Criteria: DSM-IV criteria for bipolar I disorder Screen YMRS score => 16 Women of childbearing potential agree to take adequate precautions against contraception Exclusion Criteria: Hospitalization required for treatment of psychiatric symptoms Patients who meet DSM-IV for ultra-rapid cycling History of serious suicide attempt requiring medical intervention