Overuse of Antidepressant in Patients With Alzheimer Disease and Associated Disorders : An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- AD overuse with off label prescriptions, ie no validated indication or excess in prescription duration.
研究概览
简要总结
Near 40% of French people aged 65 years and over and suffering from Alzheimer disease and associated disorders (ADAD) are exposed to antidepressants (AD) versus 13% of those without ADAD. If depression and anxiety disorders are comorbidities frequently associated with dementia, such level of AD exposure suggests an overuse of AD in this population.
Hypothesis: Overuse of AD is frequent in patients with ADAD. It is possible to assess overuse associated with off label prescriptions (no validated indication and excess in prescription duration) Main objective: to assess the prevalence of AD overuse associated with off label prescriptions (no validated indication and excess in prescription duration) in patients aged 70 years and over with ADAD.
Secondary objectives:
- To assess the prevalence of AD prescribed for a non validated indication
- To assess the prevalence of AD prescribed with excess in prescription duration
- To assess the prevalence of psychotropic coprescription and notably the prevalence of the neurologic iatrogenic alerts as defined by the French National Authority for Health
- To assess factors associated to AD overuse Method: A transversal monocentric study in the geriatric day Bretonneau unit will be performed. Study will be proposed to all eligible patients (with non-opposition of the patient or of his legal representative to the collection of his personal data). Included people will have no supplementary clinical or complementary investigations. The geriatrician in charge will have to systematically collect the indication and the history of the AD treatment. At the end of the evaluation performed in the geriatric day unit, the geriatrician will have to conclude to the AD overuse or not associated with off label prescription. Doubtful case will be examined by a validation committee.
Eligibility criteria: Patient consulting in geriatric day hospital with age ≥70 years and dementia according to DSMIV criteria, whatever its level and antidepressant prescription.
Sample size Considering that 40% of people suffering from ADAD are prescribed antidepressant (data from French Health Insurance), the number of eligible patients consulting in the geriatric day swill be 65 in 6 months. If 10% of them are opposed to the collection of their personal data and if the overuse of AD is near 50%, precision of the result will be 12.8% (95%CI bilateral).
Duration of inclusion: 6 months Duration of patient's participation: one day
详细描述
According to the data of the French Health Insurance, near 40% of French people aged 65 years and over and suffering from Alzheimer disease and associated disorders (ADAD) are exposed to antidepressants (AD) versus 13% of those without ADAD. This confirms the international data on the prevalence of antidepressant prescription in people with ADAD ranging from 26% to 56.4% but always superior to those of the population with the same age.
If depression and anxiety disorders are comorbidities frequently associated with dementia, such level of AD exposure suggests an overuse of AD in this population. This overuse has been described in people living in nursing home (among those, a majority suffers from ADAD) and would reach 62%. To assess this overuse in demented people whatever their place of living is necessary to further implement risk minimization actions.
Hypothesis : Overuse of AD is frequent in patients with ADAD. It is possible to assess overuse associated with off label prescriptions (no validated indication and excess in the prescription duration) through a transversal study.
Main objective : To assess the prevalence of AD overuse associated with off label prescriptions (no validated indication and excess in the prescription duration) in patients aged 70 years and over with ADAD.
Secondary objectives :
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥70 years,
- •Dementia according to DSMIV criteria, whatever its level,
- •Antidepressant prescription.
排除标准
- •Refusal of the patient or of his legal representative to the collection of his personal data,
- •Mild Cognitive Impairment.
结局指标
主要结局
AD overuse with off label prescriptions, ie no validated indication or excess in prescription duration.
时间窗: At inclusion
Indication for AD will be the one declared by the prescriber of AD. Off label prescription will be defined by prescription for indication not listed in the Summary of Product Characteristics (SPC). Prescription duration will be considered as exceeded if superior to that recommended in market authorization : Duration\>14 months in major depressive disorder and in patient with remission Exceeded duration according to the geriatrician in charge according to the multidisciplinary evaluation performed during the geriatric day hospital . If the geriatrician could not conclude, an expert committee (including a psycho-geriatrician and a geriatrician expert in drug) will adjudicate to the overuse or not of the AD.
次要结局
- Type and severity of dementia (Mini Mental Status, Frontal Assessment Battery, stage of dementia, etiological diagnosis)(At inclusion)
- Prevalence of psychotropic coprescription(At inclusion)
- Prevalence of the neurologic iatrogenic alerts as defined by the French National Authority for Health(At inclusion)
- Type and number of help at home (professional and non professional caregivers)(At inclusion)
- Non-drug therapy in conjunction with anti-depressant medication : yes or no (if yes, please name the therapy)(At inclusion)
- Comorbidities(At inclusion)
- Coprescription, type and number of prescriber(s)(At inclusion)