NCT00411242已完成3 期
An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2302E)
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
- 503
- 试验地点
- 1
- 主要终点
- Change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)
研究概览
简要总结
This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.
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
- •Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria
- •HAM-D17 total score > or = 22 at Screening and Baseline
- •CGI-Severity score > or = 4 at Screening and Baseline
- •Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase
排除标准
- •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
- •Concomitant psychotropic medication, including herbal preparations and melatonin
- •Psychotherapy of any type
- •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
1
Experimental
干预措施: agomelatine (Drug)
2
Experimental
干预措施: agomelatine (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 of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)
时间窗: 8 weeks
次要结局
- To evaluate the proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale(8 weeks)
- To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17(8 weeks)
- To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8(8 weeks)
- To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17(8 weeks)
- To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8(8 weeks)
研究者
研究点 (1)
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