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

Sumitomo Dainippon Pharma Co., Ltd.0 个研究点目标入组 405 人开始时间: 2015年6月1日最近更新: 2018年8月20日

适应症

试验速览

暂无简介。

•Patients who completed the prior study D1002001:
•1) 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. If the patient is a minor at the time of
•consent, written consent should be obtained from a legally acceptable representative (guardian) in addition to the patient him/herself
•2) Patients who completed the prior study and who are considered by the investigator to be eligible and without safety concerns
•3) Patients who agree to use appropriate contraception to prevent pregnancy in female patients or the female partners of patients, when the patients or their partners are of childbearing potential
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 385
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Patients who completed the prior study:
•1) Patients with a score > 4 on the Montgomery-?sberg Depression Rating Scale (MADRS) item 10 (suicidal thoughts) at Week 6 in the prior study
•2) Patients with a Yes” response to the Columbia-Suicide Severity Rating Scale (C-SSRS) item 4 (active suicidal ideation with some intent to act, without a specific plan) or item 5 (active suicidal ideation with specific plan and intent) at
•Week 6 in the prior study
•3) Patients with imminent risk of suicide or injury to self, others, or property
•4) Patients who are otherwise considered ineligible for the study by the investigator

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