NCT01986114已完成3 期
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 495
- 试验地点
- 8
- 主要终点
- Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)
研究概览
简要总结
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
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.
研究组 & 干预措施
SM-13496 20-120mg
Experimental
once daily orally SM-13496 20-120 mg flexibly dosed
干预措施: SM-13496 (Drug)
结局指标
主要结局
Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)
时间窗: 28, 52 weeks
The number and percentage of subjects with at least one adverse event and adverse drug reaction
次要结局
- Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score(Baseline, 52 weeks and each month)
- Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.(Baseline, 52 weeks and each month)
- Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.(Baseline to 52 weeks)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
3 期
A Long-Term Study of SM-13496 in Patients with Bipolar I Disorder.JPRN-jRCT2080222270Sumitomo Dainippon Pharma Co., Ltd.495
已完成
2 期
Safety and Tolerability Study of Drug to Treat SchizophreniaSchizophreniaNCT00044005Sumitomo Pharma America, Inc.98
已完成
3 期
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With SchizophreniaSchizophreniaNCT01614912Sumitomo Pharma Co., Ltd.284
已完成
2 期
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative ColitisColitis, UlcerativeNCT03648541Boehringer Ingelheim79
已完成
3 期
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.Bipolar DepressionNCT01986101Sumitomo Pharma Co., Ltd.525