EUCTR2005-003821-25-DK进行中（未招募）不适用
A 12 week multi-centre, randomized, double-blind, placebo controlled evaluation of the most efficacious and tolerable dose of escitalopram in the treatment of elderly patients. - Double-blind placebo controlled study of escitalopram in the treatment of depression in the elderly
Psychiatric Hospital0 个研究点目标入组 189 人开始时间: 2005年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 189
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All in- or out-patients of 65 years of age or above fulfilling the ICD-10 diagnosis of depressive single episode (F32.00-32.11. 32.8 or 32.9), depressive recurrent episode (F33.00-33.11, 33.8 or 33.9) or organic depressive episode (F06.32). DSM-4 criteria will be registered but will not be used for in- or exclusion
- •The depressive state should be mild to moderate and reach a score on HAM-D6 of = 7 and = 11
- •Patients with dementia can be included provided they have a MMSE score of = 17
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with a current depressive episode of a severity reaching a score of = 12 on the HAM-D6-item depression factor. This is to exclude patients with a severe or psychotic depression
- •Patients with suicidal thoughts or behaviour
- •Patients with conditions where treatment with escitalopram is contraindicated: e.g. hypersensitivity to escitalopram or other contents of escitalopram tablets, concomitant treatment with non-selective, irreversible mono-amine-oxidase inhibitors, Marplan?
- •Patients who in the current depressive episode have had a failed trial of treatment with escitalopram
- •Co-morbid dementia with a severity corresponding to a score on the MMSE of less than 17 as these patients will often be without the ability to give informed consent.
- •Patients with sensory defects rendering psychometric assessment impossible, e.g. deafness, blindness, severe aphasia
- •Patients who cannot speak Danish well enough to make psychometric assessment possible and meaningful
- •Patients with congenital or early acquired intellectual deficits
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