EUCTR2010-024371-12-IT进行中（未招募）不适用
A Multicenter, Double-Blind, 58 week Rollover Study to assess the Safety and Tolerability of BMS-820836 in Patients with Treatment Resistant Major Depression. Revised Protocol 01 Incorporating Protocol Amendment 03
BRISTOL-M.SQUIBB0 个研究点目标入组 936 人开始时间: 2012年4月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 936
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1) Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam. 2) Patients with a Cardiovascular System Organ Class adverse event(s) occurring in patients study (CN162-006 or CN162-007) that in the investigator judgment is clinically significant and would impact safety of the subject inthe current study (including but not limited to left bundle branch block or prolonged QTc) 3)In addition, patients should be excluded if they have any laboratory test, vital signs, 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.
研究者
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A Multicenter, Double-Blind, 58 week Rollover Study to assess the Safety and Tolerability ofBMS-820836 in Patients with Treatment Resistant Major DepressioCTRI/2012/07/002773Bristol Myers Squibb India Pvt Ltd500
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