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

• Status: Completed
• Trial end date: 2017-02-16
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sumitomo Dainippon Pharma Co., Ltd.
• Treatments: Lurasidone Hydrochloride

Criteria

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.