Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sumitomo Pharma Co., Ltd.
The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder.
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
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.
