CTRI/2010/091/001410已完成3 期
A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,236
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
- •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.
- •- Outpatient status at enrollment and randomization.
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 metabolism of investigational product.
研究者
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