NCT01043367已完成3 期
Efficacy of Deprexil Administration in Subjects With Signs and Symptoms of Depression.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Functional capabilities at week 24 (end of the treatment)
研究概览
简要总结
The purpose of the study is to assess the efficacy of DEPREXIL administration in combination with relaxation psychotherapy in the treatment of patients with signs and symptoms of depression. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of persons to be recruited and randomized for the study is 200.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild or moderate symptoms and signs of depression for more than 3 months and less than 3 years of duration.
- •Signed informed consent
排除标准
- •Severe symptoms and signs of depression or Suicide proneness.
- •Pregnancy or breastfeeding
- •Receiving other experimental drug
- •Use of anti-depressive medication within 15 days
研究组 & 干预措施
A
Experimental
Deprexil
干预措施: Deprexil (Dietary Supplement)
B
Placebo Comparator
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Functional capabilities at week 24 (end of the treatment)
时间窗: 24 weeks
Social capabilities at week 24 (end of the treatment)
时间窗: 24 weeks
Psycho-affective capabilities at week 24 (end of the treatment)
时间窗: 24 weeks
Behavioral capabilities at week 24 (end of the treatment)
时间窗: 24 weeks
次要结局
- Tolerability to Deprexil at week 24 (end of the treatment)(24 weeks)
- Symptoms of depression at week 24 (end of the treatment)(24 weeks)
- Signs of depression at week 24 (end of the treatment)(24 weeks)
- Clinical symptoms of baseline disease at 24 weeks (end of the treatment)(24 weeks)
研究者
研究点 (1)
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