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 495 人开始时间: 2013年10月30日最近更新: 2023年10月17日

试验速览

阶段: 3 期
状态: 已完成
发起方: Sumitomo Dainippon Pharma Co., Ltd.
入组人数: 495

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Overall, long-term treatment with SM-13496 was effective for bipolar I disorder. SM-13496 was generally safe and well tolerated when used for up to 28 or 52 weeks.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 18age old 至 <= 74age old（—）
性别: All

入选标准

•Patients who completed the prior placebo controlled study
•-Patients who completed the prior study and who are considered by the investigator to be eligible and without safety concerns.
•Patients who did not participate in the prior placebo controlled 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.
•-Patients 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)

排除标准

•- 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.

研究者

发起方

Sumitomo Dainippon Pharma Co., Ltd.

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