NCT00130455终止4 期
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
Psychiatric Hospital, Hillerod2 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2006年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Remission during the study is defined as a Hamilton 6-item depression subscale (HAM-D6) score less than or equal to 4
研究概览
简要总结
The study is designed to establish the efficacy and tolerability of escitalopram in the treatment of depressive episodes of mild to moderate severity in the elderly.
The study is designed as a mainly naturalistic study including all patients of 65 years of age or above that judged by the clinician would benefit from treatment by an antidepressant medication. The study is designed as a double-blind, randomised placebo controlled study with two groups of active treatment (escitalopram in two doses, 5 or 10 mg daily) in a twelve week period.
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
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In- or out-patients of 65 years of age or above fulfilling the International Classification of Diseases-Tenth Edition (ICD-10) diagnosis of depressive single episode (F32.00-32.
- •32.8 or 32.9), depressive recurrent episode (F33.00-33.11, 33.8 or 33.9) or organic depressive episode (F06.32).
- •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 mini mental state exam (MMSE) score of ≥ 17
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 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, such as 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
结局指标
主要结局
Remission during the study is defined as a Hamilton 6-item depression subscale (HAM-D6) score less than or equal to 4
Response will be defined as a drop in HAM-D6 score of 50% or more
次要结局
未报告次要终点
研究者
研究点 (2)
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