A 52-week, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of the Long-term Efficacy, Tolerability and Safety of Agomelatine 25 and 50 mg in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-label Treatment of 16-24 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 644
- 试验地点
- 1
- 主要终点
- suicide attempt or suicide;
研究概览
简要总结
This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria
- •A history of at least two previous episodes of Major Depression plus the current episode
- •Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline
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
- •Use of any psychoactive medication after the screening visit
- •Patients who have been previously treated with 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
1
干预措施: agomelatine (Drug)
2
干预措施: agomelatine (Drug)
3
干预措施: placebo (Drug)
结局指标
主要结局
suicide attempt or suicide;
时间窗: Primary efficacy variable is measured from randomization to relapse
Time to relapse, where relapse is defined by the occurrence of any one of the following:
时间窗: Primary efficacy variable is measured from randomization to relapse
discontinuation due to lack of efficacy according to Investigator judgment.
时间窗: Primary efficacy variable is measured from randomization to relapse
hospitalization due to depression;
时间窗: Primary efficacy variable is measured from randomization to relapse
Hamilton Depression Rating Scale total score ≥16 at two consecutive visits;
时间窗: Primary efficacy variable is measured from randomization to relapse
次要结局
- Change from randomization to the end of the double-blind continuation phase, on the Hospital Anxiety and Depression (HAD) total score and subscale scores.(Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase)
- Proportion of patients who achieve remission at the end of the double-blind continuation phase, where remission is defined by a total score of ≤7 on the HAM-D.(Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase)
- Proportion of patients who demonstrate clinical improvement at the end of the double-blind continuation phase, where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale.(Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase)
- Proportion of patients experiencing relapse during the double-blind continuation phase.(Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase)