NCT00551109已完成2 期
A Phase II, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Safety and Efficacy of Treatment With SA4503, Once Daily for 8 Weeks, in Subjects With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Montgomery-Åsberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this study is to determine the efficacy of SA4503 compared to placebo in the treatment of subjects with major depressive disorder (MDD). Secondary, to evaluate the safety of SA4503 compared to placebo in subjects with MDD.
详细描述
Further study details as provided by M's Science Corporation:
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 18 and 65 (inclusive)
- •Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV criteria and a shortened MINI evaluation
- •HAM-D17 score of >/= 21 and a severity score of at least 2 for Item 1 (depressed mood) at both Screening and Baseline
- •Current depressive episode of at least 3 months duration, and significant depressed mood and anhedonia in the 4 weeks prior to Screening.
排除标准
- •Subjects who have received fluoxetine within 1 month prior to Baseline or any other antidepressant within 2 weeks prior to Baseline, or any unlicensed medication within 1 month before Screening
- •Subjects who require psychotropic medication other than the study medication
- •Subjects who started psychotherapy within 4 months prior to Screening
- •Subjects who currently (i.e., in the month prior to Screening) meet DSM-IV criteria for bipolar syndrome or psychotic depression or severe somatoform or eating disorders
- •Subjects who have a primary diagnosis of anxiety
- •Subjects who regularly use sleeping medication more than 3 times per week
- •Subjects who have major psychiatric or neurologic disorders other than MDD
- •Subjects with depression secondary to stroke, cancer, or other severe medical illness
- •Subjects who have a history of alcohol or substance dependence(within 1 year prior to Screening)
研究组 & 干预措施
P
Placebo Comparator
Placebo
干预措施: placebo (Drug)
A1
Experimental
SA4503
干预措施: SA4503 Low (Drug)
A2
Experimental
SA4503
干预措施: SA4503 High (Drug)
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
Safety and Efficacy of SPD503 in Treating ADHD in Children and Adolescents Aged 6-17Attention Deficit Disorder With HyperactivityNCT00150618Shire324
已完成
3 期
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the KneeKnee OsteoarthritisNCT06000410Organogenesis594
已完成
3 期
Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the KneeKnee OsteoarthritisNCT04636229Organogenesis516
已完成
3 期
Efficacy and Safety of SPD465 in Adults With ADHDAttention Deficit Disorder With HyperactivityNCT00150579Shire240
已完成
3 期
Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic ADHD.Attention Deficit Disorder With HyperactivityNCT00152022Shire412