NCT01437657已完成2 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 319
- 主要终点
- Change in Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on study treatment is 6 weeks with a 3-week follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
Placebo
Placebo Comparator
Matching RO4917523 placebo orally daily, 6 weeks
干预措施: Placebo (Drug)
RO4917523 0.5 mg
Experimental
0.5 mg orally daily, 6 weeks
干预措施: RO4917523 0.5 mg (Drug)
RO4917523 1.5 mg
Experimental
1.5 mg orally daily, 6 weeks
干预措施: RO4917523 1.5 mg (Drug)
结局指标
主要结局
Change in Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: From baseline to Week 6
次要结局
- Proportion of patients exhibiting remission (MADRS </= 10) after 6 weeks of treatment(approximately 2 years)
- Proportion of patients exhibiting response (reduction in MADRS >/= 50% of baseline score) after 6 weeks of treatment(approximately 2 years)
- Safety: Incidence of adverse events(approximately 2 years)
- Change in Clinical Global Impression Score - Severity (CGI-S)(From baseline to Week 6)
- Change in Clinical Global Impression Score - Improvement (CGI-I)(From baseline to Week 6)
研究者
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