A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.

• Status: Completed
• Trial end date: 2018-02-17
• Target enrollment: 0
• Participant gender: All

Summary

The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.

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

Details

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

Criteria

Inclusion Criteria:

Patients who completed the D1002001 study

・Patients who completed the D1002001 study and who are considered by the investigator to be eligible and without safety concerns.

Patients who did not participate in the D1002001 study

• 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 manic, hypomanic, or mixed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance, but < 8 episodes in the previous 12 months prior to screening).

Exclusion Criteria:

• Patients with imminent risk of suicide or injury to self, others, or property.

• Patients who are otherwise considered ineligible for the study by the investigator.