Evolution of Dark Ideas When Introducing or Switching an Antidepressant: Hetero-evaluation and Use of a Smartphone Application in the Monitoring of Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Values of dark ideas assessed with a Likert type scale [1;5]
研究概览
简要总结
Depression is a frequent disease and a serious public health problem, of which suicide is the most severe complication. Its treatment is based on the introduction of antidepressant which not only proposes a significant delay in the relief of symptoms but also by the phenomenon of lifting of inhibition can increase the suicidal risk during the initiation phase. Therefore there is a major interest in proposing a monitoring of these dark and suicidal ideas, immediately after the implementation of such treatment as well as other symptoms of depression. Thus, the aim of this study is to identify the mechanisms underlying this increase in dark and suicidal ideas in this context.
详细描述
The study propose to assess, with an ecological momentary assessment method, the evolution of black ideas over 30 days following the introduction or switch of an oral antidepressants.
103 patients will be recruited suffering from a current major depressive disorder in the Montpellier University Hospital.
Each patient will attend a total of 3 scheduled visits, which will be completed over a period of 1 month (inclusion, between 10-15 days, 1 month. During this month, the patient will have to complete daily assesments throught a smartphone application "Depasse".
This Servier application allows the daily monitoring of symptoms allowing a regular evaluation, in the form of smileys simulating a Likert type scale evaluation of 1 to 5.
10 parameters are evaluated: moral, black thoughts, sleep, stress, concentration, social activities, energy, pleasure, motivation and libido. Note that when the patient expresses dark thoughts, he is then asked if he wants to hurt himself. If he answers yes, he is then asked to contact an emergency service.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Values of dark ideas assessed with a Likert type scale [1;5]
时间窗: 1 month
Evolution of dark ideas over 30 days. Throught the DEPASSE smartphone application, the patient assess the actual frequency of dark ideas from a Likert type scale of 1 (= not at all) to 5 (= often)
次要结局
- Values of the actual mood assessed with a Lickert type scale [1;5](1 month)
- Values of the actual motivation assessed with a Lickert type scale [1;5](1 month)
- Values of the ability to feel pleasure as usual assessed with a Lickert type scale [1;5](1 month)
- Values of the energy assessed with a Lickert type scale [1;5](1 month)
- Values of the social activities assessed with a Lickert type scale [1;5](1 month)
- Values of the concentration assessed with a Lickert type scale [1;5](1 month)
- Values of the stress assessed with a Lickert type scale [1;5](1 month)
- Values of the libido assessed with a Lickert type scale [1;5](1 month)
- Values of sleep assessed with a Lickert type scale [1;5](1 month)
- Score at the Montgomery-Åsberg Depression Rating Scale (MADRS)(1 month)
- Score at the Columbia Suicide Severity Rating Scale (CSSRS)(1 month)
- Number of emergency room visits(1 month)
- Number of hospitalizations(1 month)
- Satisfaction score on the Lickert type scale [1;5](1 month)