Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Completion Rate
研究概览
简要总结
Benzodiazepines (BZDs) have been reported to cause negative impacts on motor as well as cognitive functions, which in turn could result in lethal incidents including falls especially in the elderly. This notwithstanding, few trials have evaluated a feasibility and benefits of discontinuing BZD-derivative hypnotics in a systematic manner in this frail population. In this 8-week open-label study, we examined changes in motor and cognitive functions following the discontinuation of BZD hypnotics in older persons.
OBJECTIVES & HYPOTHESES
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Primary Objective The primary objective is to examine the feasibility of discontinuing BZD-derivative hypnotics in older people.
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Secondary Objectives
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One of the secondary objectives is to examine the magnitude of discontinuing BZD-derivative hypnotics in the stability of body.
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Another secondary objective is to examine the magnitude of discontinuing BZD-derivative hypnotics in cognitive function.
Hypotheses
- More than 80% of the participants will complete and tolerate all the study procedures.
2a. Participants will show an improvement in the stability of body. 2b. Participants will show an improvement in the cognitive function globally as well as specifically in attention.
详细描述
Benzodiazepines (BZDs) have been reported to cause negative impacts on motor as well as cognitive functions, which in turn could result in lethal incidents including falls especially in the elderly. This notwithstanding, few trials have evaluated a feasibility and benefits of discontinuing BZD-derivative hypnotics in a systematic manner in this frail population. In this study, we examined changes in motor and cognitive functions following the discontinuation of BZD hypnotics in older persons.
In this 8-week open-label study, subjects aged 50 or older who receive BZD as a hypnotic and do not have any unstable physical illness, or neurological disorder will be recruited. The BZD dose will be discontinued in 4 weeks by a weekly 25% reduction.
Following assessments will be performed at baseline 12 hours postdose and at endpoint: the Clinical Stabilometric Platform (CSP), the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Critical Flicker Fusion Test (CFF), the Leeds Sleep Evaluation Questionnaire (LSEQ). The CSP measures the stability of body, with the eyes opened or closed.
All psychotropic agents other than the BZD-derivative hypnotics will be kept constant throughout the study.
The dose reduction will be terminated if any of the following conditions are fulfilled:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants of any race or ethnicity with any psychiatric diagnosis
- •Age of 50 and older
- •Having been treated with an BZD-derivative hypnotic drug at a steady dose for at least 4 weeks
排除标准
- •Incapacity to follow the instructions.
- •Unstable physical illness or significant neurological disorder
- •Psychiatric concerns raised by the physician of record regarding participation in the study.
结局指标
主要结局
Completion Rate
时间窗: 8 weeks
The number of subjects who have successfully completed dose-reduction and all the assessments scheduled until week 8 divided by the total number of enrolled subjects
次要结局
- A Change in a Total Scale Score in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Japanese Version, From Baseline to Week 8.(Baseline and week 8)
- Clinical Stabilometric Platform (CSP)(Baseline and week 8)
- Critical Flicker Fusion Test (CFF)(Baseline and week 8)
- Leeds Sleep Evaluation Questionnaire (LSEQ)(Week 8)
- Clinical Global Impression (CGI)(Week 8)