Randomized, Double Blind, Efficacy Study of Escitalopram Versus Placebo in ENT Cancer Patients Suffering From Emotional Distress
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Efficacy of treatment by Escitalopram on depressive symptoms
研究概览
简要总结
Escitalopram is an antidepressant inhibitor of the serotonin reuptake. On the market in France since 2002.
Prevalence of emotional distress in patients with cancer is 30-50%. this prevalence may vary regarding the tumor localisation, the population, intensity of the symptoms...
Incidence of ENT cancer is highly significant in France, it is one of the most important in the world 37 out of 100 000. it is in patients with ENT cancer that the prevalence of depression is the most important (22%-57%).
Researches appears necessary to assessed the efficacy of antidepressant treatments with as primary objective not only the decrease of depressive symptoms but also an ensemble of physic and psychological symptoms.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ENT cancer of stage I to IVb that have to go under surgery and/or radiotherapy and/or chemotherapy as first line treatment. It may be a primary cancer or a new localisation.
- •Total score on HADS scale >11
- •Patients aged from 18 to 75 years
- •Signed informed consent
- •OMS < 2, hospitalized or ambulatory
- •Are authorized to inclusion, psychoactive treatments at stable dosage for two weeks for benzodiazepins, neuroleptics, antihistaminics or other anxiolytics or hypnotics
排除标准
- •Patients in palliative treatments
- •Previous bipolar disorder or schizophrenia
- •Major depressive episode with severity criteria
- •Suicidal patients
- •Acute infection
- •ASAT/ALAT >3N
- •Creatinine clearance <30 ml/mn
- •Natremia inferior to the laboratory standard
- •For alcoholic patients non abstinent at the time of inclusion, previous "delirium tremens"
- •Previous upper gist bleeding
- •Inefficacy or intolerance of previous treatment by escitalopram
- •Not compatible concomitant treatment:
- •Other antidepressive than escitalopram (except clonazepam)
- •all hypnotics (except zolpidem)
- •all anxiolytics (except clonazepam, clorazepate and diazepam)
- •medical treatment for smoking addiction like bupropion or varenicline
- •Pregnant or breastfeeding women
- •Patients under guardianship
- •Patients without insurance
- •Impossibility to follow the protocol for geographical, social or psychic reasons
- •Insufficient knowledge of French
研究组 & 干预措施
Escitalopram
10 mg once per day
干预措施: Escitalopram (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Efficacy of treatment by Escitalopram on depressive symptoms
时间窗: Assessed 3 months after randomization
Assessed using HADS scale
次要结局
- Efficacy of treatment on emotional distress(Assessed 3 months after randomization)