JPRN-jRCT2080221839未知1 期
A Randomized, Double-blind, Parallel-group Study of the Safety and Efficacy of RO4917523 Versus Placebo, as Adjunctive Therapy in Patients With Major Depressive Disorder With Inadequate Response to Ongoing Antidepressant Treatment
Hoffmann-La Roche Ltd, Chugai Pharmaceutical Co., Ltd.0 个研究点目标入组 300 人开始时间: 2012年6月28日最近更新:
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 300
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
- 年龄范围
- >= 18age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •Adult patient, 18 to 70 years of age at time of informed consent
- •- Major depressive disorder without psychotic features as defined by DSM-IV-TR criteria
- •- Inadequate response to ongoing antidepressant treatment, as defined by protocol
- •- Body mass index (BMI) 18 to 38 kg/m2 inclusive
排除标准
- •- Currently receiving treatment with a combination of antidepressants (two or more), or an adjunctive potentiating treatment as defined by protocol
- •- Previously received RO4917523
- •- History of failure, or utilization during the current episode of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
- •- History of use at any time of Vagus Nerve Stimulation (VNS) or Deep Brain Stimulation (DBS)
- •- Current or past history of bipolar disorder (e.g. manic, hypomanic, or mixed episodes)
- •- Pregnant or lactating women
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