跳至主要内容
临床试验/EUCTR2010-019925-33-DE
EUCTR2010-019925-33-DE进行中(未招募)不适用

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

AstraZeneca AB0 个研究点目标入组 940 人开始时间: 2010年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
940

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

  • Provision of signed and dated informed consent before initiation of any study-related procedures.
  • The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
  • Out-patient status at enrollment and randomization.
  • 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 893
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range 47

排除标准

  • Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
  • Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a signficant history of risk of suicide or homicide.
  • History of renal insufficiency or impairment or conditions that could affect absorption or metabilism of the investigationl product in this patient population

研究者

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