NCT01361555终止2 期
A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression
Bristol-Myers Squibb86 个研究点 分布在 1 个国家目标入组 789 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 789
- 试验地点
- 86
- 主要终点
- Long-term effects of BMS-820836 on blood pressure in patients with depression
研究概览
简要总结
The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women of age 18-65 years (Argentina the minimum age will be 24 years of age)
- •Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study.
- •Patient not randomized in parent study that meet inadequate response criteria
排除标准
- •Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam.
- •Patients with a Cardiovascular System Organ Class adverse event(s) occurring in parent study (CN162-006 or CN162-007), that in the investigators judgment is clinically significant and would impact safety of the subject in the current study [including but not limited to left bundle branch block, or prolonged QT interval corrected (QTc)].
- •In addition, patients should be excluded if they have any laboratory test, vital sign, electrocardiogram (ECG) or clinical findings that in the investigator's judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study.
研究组 & 干预措施
Arm 3: Placebo + BMS-820836 (2 mg/day)
Experimental
干预措施: Placebo matching with BMS-820836 (Drug)
Arm 3: Placebo + BMS-820836 (2 mg/day)
Experimental
干预措施: BMS-820836 (Drug)
Arm 1: Placebo + BMS-820836 (0.5 mg/day)
Experimental
干预措施: Placebo matching with BMS-820836 (Drug)
Arm 1: Placebo + BMS-820836 (0.5 mg/day)
Experimental
干预措施: BMS-820836 (Drug)
Arm 2: Placebo + BMS-820836 (1 mg/day)
Experimental
干预措施: Placebo matching with BMS-820836 (Drug)
Arm 2: Placebo + BMS-820836 (1 mg/day)
Experimental
干预措施: BMS-820836 (Drug)
结局指标
主要结局
Long-term effects of BMS-820836 on blood pressure in patients with depression
时间窗: Baseline through Week 54
次要结局
- • Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs(Baseline through Week 54)
研究者
研究点 (86)
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