Efficacy of Pain Treatment on Depression in Patients With Dementia. A Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Change in the Cornell Scale for Depression in Dementia (CSDD)
研究概览
简要总结
The purpose of this study is to determine whether pain treatment can reduce symptoms of depression in patients suffering from dementia and depression. Depression is commonly diagnosed in patients with dementia. If the investigators find a reduction in depressive symptoms when pain treatment is applied, this will support the hypothesis that undiagnosed pain may present itself as depression in patients with dementia.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients residing in long term nursing home units for at least 4 weeks prior to study
- •Diagnosed with probable or possible dementia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), FAST score > 4
- •Diagnosed with depression ≥ 4 week duration as measured by CSDD ≥ 8
- •Written, informed consent provided by the participant (if they have capacity) or assent (if they do not have capacity) and a written proxy informed consent from a legally authorized representative empowered to make health-related decisions for the potential study participant
排除标准
- •The patient is contra-indicated to study drugs of pain treatment, in another trial, or had no carer.
- •Participants are ineligible if they are clinical critical (e.g. suicide risk)
- •Clinician responsible for care, or study clinician considers that the patient suffers from any physical condition, which would make participation in the trial distressing or likely to increase suffering
- •Advanced severe medical disease/disorder with expected survival less than 6 months or that could interfere with participation
- •Psychosis or other severe mental disorder prior to dementia diagnosis
- •Severe aggression (≥8) on item 3 of the NPI subscale, with aggression as the predominant symptom
- •Schizophrenia, schizoaffective disorder and bipolar disorder
- •Uncontrolled epilepsy
- •Severe liver impairment
- •Renal failure
- •Severe injury or anaemia (Hb < 8.5 mmol/l), comatose state, current enrolment in another experimental protocol
- •Known allergy or adverse reaction to paracetamol or buprenorphine transdermal patch
- •Advanced severe medical disease with expected survival of less than six months, severe psychiatric or neurological disorder.
- •Patients with diseases that make it impossible to follow the research schedule are excluded
研究组 & 干预措施
Paracetamol or buprenorphine treatment
Paracetamol tablets 1 g three times daily or Buprenorphine transdermal system 5 micrograms/hour every 7 days, may be titrated up to 10 micrograms/hour every 7 days if clinically appropriate.
干预措施: Paracetamol (Drug)
Paracetamol or buprenorphine treatment
Paracetamol tablets 1 g three times daily or Buprenorphine transdermal system 5 micrograms/hour every 7 days, may be titrated up to 10 micrograms/hour every 7 days if clinically appropriate.
干预措施: Buprenorphine (Drug)
Paracetamol placebo or buprenorphine placebo
Paracetamol placebo tablet three times daily or buprenorphine transdermal system placebo every 7 days.
干预措施: Paracetamol placebo (Drug)
Paracetamol placebo or buprenorphine placebo
Paracetamol placebo tablet three times daily or buprenorphine transdermal system placebo every 7 days.
干预措施: Buprenorphine placebo (Drug)
结局指标
主要结局
Change in the Cornell Scale for Depression in Dementia (CSDD)
时间窗: Week -2, week 0, week 6 and week 13
次要结局
- Change in the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH)(Week -1, week 0, week 6 and week 13)
- Change in the Mini-Mental State Examination (MMSE)(Week -1 and week 13)
- Change in the Mobilization- Observation - Behavior - Intensity - Dementia-2 (MOBID-2) Pain Scale(Week -1, week 0, week 6 and week 13)
- Change in actigraphy recorded sleep patterns and circadian rhythm(Week -1 to 0 and week 12 to 13)
- Change in the Numerical Rating Scale (NRS)(Week 0, week 6 and week 13)
- Change in the Quality of life in late-stage dementia (QUALID) scale(Week -1, week 0, week 6 and week 13)
- Change in the EuroQoL Quality of Life Scale (EQ-5D)(Week -1, week 0, week 6 and week 13)
- Adverse events (AE) and serious adverse event (SAE)(Weeks 0-13)
研究者
Bettina Husebo
MD, assoc prof. University of Bergen
University of Bergen