Evaluation of the Relevance of Pharmacogenetics in the Prescription Off Antidepressants in a Military Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Proportion of patients with a Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale deleterious score ≤ 2 after 8 weeks of treatment
研究概览
简要总结
The treatment of depression, anxiety disorders and post-traumatic stress disorder (PTSD) is a main public health problem due to the frequency of these pathologies and the very partial effectiveness of the existent therapies. These illnesses generally require the prescription of several successive lines of antidepressant treatments before the treatments actually become effective, leading to a several week delay during which the patient suffers from the symptoms of his/her pathology and is also likely to experience the side effects of the treatment.
Pharmacogenetics is an individualized prescribing modality that aims to predict the most favorable treatment for a given individual based on the study of genetic variants of cytochromes.
The main hypothesis of this research is that the use of pharmacogenetics in routine practice in a population of military personnel requiring a first prescription of an antidepressant is of interest to improve the tolerance and effectiveness of the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Between 18 and 65 years-old;
- •To benefit from a medical follow-up in the psychiatric department of an army training hospital;
- •To present a pathology requiring an antidepressant treatment and whose prescription can wait 10 days;
- •To have given written informed consent to participate in the study.
排除标准
- •To be currently treated with an antidepressant or antidepressant stopped less than 15 days ago;
- •To have one or more contraindication to the introduction of an antidepressant treatment;
- •Pregnancy or breastfeeding;
- •To require a measure of constraint.
结局指标
主要结局
Proportion of patients with a Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scale deleterious score ≤ 2 after 8 weeks of treatment
时间窗: 8 weeks after antidepressant treatment initiation
This endpoint will allow to assess the clinical tolerance of antidepressant treatment and to compare the results between the 2 arms. The FIBSER scale score ranges from 0 to 18 with higher scores reflecting more deleterious side effects.
次要结局
未报告次要终点