NCT00319709已完成3 期
An Eight-Week, Double-Blind Placebo Controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Elderly Patients With Major Depressive Disorder (MDD)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 288
- 试验地点
- 5
- 主要终点
- The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in elderly patients with depression. The secondary objectives are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability and quality of life in elderly patients with depression.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients or inpatients
- •Major Depressive Disorder (MDD) with a recurrent Major Depressive Episode (MDE) according to DSM IV-TR criteria.
- •MADRS score equal of above 22.
排除标准
- •Patients with a current significant risk of suicide in the investigator's clinical judgment.
- •The duration of the current depressive episode is greater than 2 years.
- •Patients whose current depressive episode is secondary to a general medical condition
- •Patients with a lifetime history according to MINI at screening of:bipolar disorder, psychotic disorder, antisocial personality disorder.
- •Patients with a current history according to MINI at screening of anxiety disorders, alcohol dependence or abuse or substance dependence or abuse
- •Patients with severe or unstable concomitant medical conditions.
- •History of seizures other than a single childhood febrile seizure.
- •Patients with abnormal thyroid functioning.
- •Patients with clinically significant ECG findings at screening.
- •Patients who have taken an investigational drug in the last 3 months prior to screening.
- •Any subject who has previously participated in a SR58611A protocol.
- •Patients with Mini-Mental State Examination (MMSE) score < 25 at screening.
结局指标
主要结局
The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.
次要结局
- The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.
研究者
研究点 (5)
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