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 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.
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
