NCT00463242已完成3 期
An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 501
- 试验地点
- 1
- 主要终点
- Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale
研究概览
简要总结
This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male and female adults, 18 through 70 years of age, inclusive
- •Diagnosis of Major Depressive Disorder according to DSM-IV criteria
- •HAM-D17 total score > or = 22 at Screening and Baseline
排除标准
- •History of non-response to paroxetine
- •Patients who have been previously treated with agomelatine
- •History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
- •Any current Axis I disorder other than major depressive disorder which is the focus of treatment
- •Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
- •Use of any psychoactive medication after the screening visit
- •Female patients of childbearing potential who are not using effective contraception
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Agomelatine
Experimental
Dosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began.
干预措施: Agomelatine (Drug)
2
Active Comparator
干预措施: paroxetine (Drug)
3
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale
时间窗: 8 weeks
次要结局
- To demonstrate less sexual dysfunction in patients with MDD receiving agomelatine compared to paroxetine, as measured by the change from baseline to Week 8 on the total score of the Arizona Sexual Experience Scale (ASEX).(8 weeks)
- Proportion of patients who demonstrate clinical improvement where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale at Week 8.(8 weeks)
- Proportion of patients with MDD who achieve remission,(8 weeks)
- Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD).(8 weeks)
研究者
研究点 (1)
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