EUCTR2011-005878-37-ES进行中（未招募）1 期
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 Major Depressive Disorder
Aziende Chimiche Riunite Angelini Francesco - ACRAF S.p.A.0 个研究点目标入组 360 人开始时间: 2012年8月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •Outpatients; Men or women 18-75 years of age (limits included); diagnosis of MDD according to DSM-IV; HAMD -17 ? 18 at screening and baseline visits; symptoms of depression for at least 1 month; patients legally capable to give their consent to participate the study, subjects must agree not to start a pregnancy from the signature of the informed consent (childbearing women).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •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 6 months; liver or renal clinically significant disease; myocardial infarction (within 6 months); positive present history of glaucoma; risk factors for TdP; clinically significant electrolyte values; concomitant treatment with drugs known for QT prolongation; QTcF > 450msec; major depression resistant to medical treatments; seizure events; alcohol or psychoactive abuse or addiction; suicide risk (HAMD, criterion 3 value ? 3); present history of psychiatric disorder rather than MDD; pregnant or lactating women; use of antipsychotic, anxiolytic or sedative hypnotic; use of drugs with psychotropic effect; treatment with CYP3A4 inhibitors; hyperthyroidism;clinically significant alterations at physical examination, vital signs, ECG and laboratory exams; vulnerable subjects.
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