EUCTR2011-005878-37-IT进行中（未招募）不适用
A randomized, double-blind study comparing the efficacy and safety of trazodone OAD and venlafaxine XR in the treatment of patients with Major Depressive Disorder - trazodone OAD in MDD
ANGELINI0 个研究点目标入组 360 人开始时间: 2012年6月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
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
- •Men and women outpatients >=18 years of age;major depressive disorder according to DSM-IV criteria;HAMD17 score >=18 at both screening and baseline visits;symptoms of depression for at least one month;legally capable to give their written informed consent;women of childbearing potential must agree not to start a pregnancy from the signature of the informed consent
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •use of venlafaxine or trazodone within the previous six months; clinically significant hepatic or renal diseases; myocardial infarction (within 6 months); positive present history of glaucoma; history of risk factors for Torsade de Pointes; clinically abnormal electrolytes values; concomitant treatment with drugs known for QT prolongation; QTcF values higher than 450 msec;resistant major depression; seizure events, alcohol or psychoactive substance abuse or addiction; acute risk of suicide (HAMD, criterion 3 with a value > 3); presence of any primary psychiatric disorder other than major depression; pregnancy, lactation; use of antipsychotic drugs; any anxiolytic or sedative hypnotic drug; any drugs with psychotropic effects; concomitant treatment with CYP3A4 inhibitors; hyperthyroidism, clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests; vulnerable subjects
研究者
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