Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 8
- 主要终点
- Changes in UPDRS subscale
研究概览
简要总结
The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).
详细描述
Patients with dementia have cognitive deficits, but also hallucinations, delusions, agitation, aggression and apathy. These symptoms are called Behavioural- and Psychological Symptoms in Dementia (BPSD), and are difficult to treat. Antipsychotic and antidepressant medication is used as treatment, despite its lack of clinical evidence.
We will discontinue risperidone in one group of 30 patients and compere them to 30 controls and we will discontinue antidepressants in a group of 76 patients and compere them to 76 controls. Patients should have dementia of Alzheimer- or vascular origin. They should live in Nursing Homes and have no other psychiatric disease for which they receive psychotropic drug. They will be registered with 7 different questionnaires at baseline and after 3, 6, 12 and 24 weeks. The study period is 24 weeks. The questionnaires are filled in by the patients and the nurses at the nursing homes.
This is a double blind RCT study with placebo-controlled group.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vascular- or Alzheimer Dementia
- •Nursing Homes resident for 3 months or more
- •Given antipsychotics or antidepressants for 3 months or more
- •Clinical Dementia rating 1, 2 or 3
排除标准
- •Dementia of other origin
- •Psychiatric disease
- •Life expectancy less than 3 months
- •Acute infection last 10 days
- •Unstable Diabetes Mellitus
- •Terminal disease
研究组 & 干预措施
A
Discontinuation of antipsychotic or antidepressants
干预措施: Risperidone (Drug)
A
Discontinuation of antipsychotic or antidepressants
干预措施: Escitalopram (Drug)
A
Discontinuation of antipsychotic or antidepressants
干预措施: Citalopram (Drug)
A
Discontinuation of antipsychotic or antidepressants
干预措施: Sertraline (Drug)
A
Discontinuation of antipsychotic or antidepressants
干预措施: Paroxetine (Drug)
结局指标
主要结局
Changes in UPDRS subscale
时间窗: 24 weeks
Changes in Cornell's Depression Scale
时间窗: 24 weeks
Changes in Neuropsychiatric Inventory
时间窗: 24 weeks
次要结局
- Changes in Severe Impairment Battery(24 weeks)
- Changes in Lawton's PADL(24 weeks)
- Oxazepam given p.n.(24 weeks)
- Number of falls(24 weeks)
- Changes in Body Weight(24 weeks)
- Quality of Life - Alzheimer disease(24 weeks)
- Clinical Dementia Rating(24 weeks)