NCT00935675Unknown3 期
Double-blind, Placebo-controlled, Randomized Study of the Effectiveness of Escitalopram on Emotional Distress of Head and Neck Cancer Patients During Cancer Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months
研究概览
简要总结
Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months in patients with head and neck squamous cell carcinomas (oral cavity, larynx, oropharynx and hypopharynx) and with an HADS total score > 11
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Head and neck squamous cell carcinomas, stage I to IVb
- •First-line curative cancer therapy : surgery and/or brachytherapy and/or chemotherapy
- •HADS- T >11
- •Aged 18 to 75 yo, written consent required
排除标准
- •Palliative care
- •Previous head and neck cancer
- •Bipolar disorder or schizophrenia
- •Severe major depressive disorder (DSM-IV TR)
- •Expressed suicidal ideation
- •Severe untreated organic disorder, especially acute infectious disorder
- •ASAT/ALAT > 3N
- •Clearance of creatinin < 30 ml/mn
- •Hyponatremia
- •Antecedent of delirium tremens or acute alcohol withdrawal disorder
- •Antecedent of upper gastro-intestinal bleeding
- •Antecedent of toxicity or inefficacy of a previous treatment with escitalopram
- •Unauthorized treatments :- Antidepressant or antiepileptic (clonazepam authorized)- Hypnotic except zolpidem - Anxiolytic except clonazepam, clorazepate or diazepam- bupropion or varenicline
- •Pregnancy or lactation
研究组 & 干预措施
Antidepressant treatment
Active Comparator
干预措施: Escitalopram (Drug)
Placebo
Placebo Comparator
干预措施: Escitalopram (Drug)
结局指标
主要结局
Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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