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

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.

The primary objective is to compare the efficacy of SM-13496 (20-60 or 80-120 mg/day) monotherapy with that of placebo in patients with depressive symptoms associated with bipolar I disorder by assessing the change from baseline in the MADRS total score at Week 6.

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.