NCT01110902已完成3 期
A 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 589
- 试验地点
- 45
- 主要终点
- Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale
研究概览
简要总结
The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind 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
- •Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
- •Current episode ≥4 weeks.
- •CGI-Severity score ≥4 at Screening and Baseline.
排除标准
- •History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
- •Any other current Axis I disorder other than MDD 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.
- •Prior exposure to agomelatine.
- •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
AGO178C 0.5 mg /day
Experimental
干预措施: Agomelatine (AGO178C) (Drug)
AGO178C 1 mg / day
Experimental
干预措施: Agomelatine (AGO178C) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale
时间窗: Baseline and 8 weeks
次要结局
- 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)
- Proportion of patients who achieve remission(8 weeks)
- Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8(8 weeks)
- Proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the Baseline clinician-rated HAM-D total score at Week 8 endpoint(8 weeks)
- Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale.(8 weeks)
研究者
研究点 (45)
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