CTRI/2010/091/001491已完成3 期
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 With an Inadequate Response to Antidepressant Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入排标准
入选标准
- •1.Provision of signed and dated informed consent before initiation of any study-related procedures.
- •2.The patient must have a clinical diagnosis of major depressive disorder (MDD) with inadequate response to no more than one antidepressant.
- •3.Out-patient status at enrollment and randomization.
排除标准
- •1.Patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder.
- •2.Patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide.
- •3.History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of the investigational product in this patient population
研究者
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