A Phase III Study of SM-13496 in Patients With Bipolar I Depression.

Inclusion Criteria: * Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study. * Outpatients aged 18 through 74 years at the time of consent * Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode depressed (≥ 4 weeks and less than 12 months) without psychotic features. Exclusion Criteria: * Patients with imminent risk of suicide or injury to self, others, or property. * Patients who had been hospitalized because of a manic or mixed episode within 60 days prior to screening. * Patients who are otherwise considered ineligible for the study by the investigator.