The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD) - An Eight Week Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi Center Trial. A Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version)
研究概览
简要总结
We intend to conduct a phase III b trial to verify Oxcarbazepine's effect in agitation and aggression in patients with dementia. We designed the study as a randomized, double-blind, placebo-controlled multi center trial. Hundred patients will be included. The treatment period will be eight weeks, with a further follow up of four weeks.
The primary outcome measure will be the reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version). Secondary outcomes are reduction in aggression as measured by BARS (Behavior Agitation Rating Scale)and reduction in the burden to health-care personnel as measured by NPI-NH.
详细描述
Inclusion criteria: Patients of either gender, 55 years of age or older, living in a nursing home diagnosed with or a strong suspicion of dementia of Alzheimer's type or vascular origin, and BPSD in form of agitation / aggression as measured by subscale of NPI-NH and BARS.
Exclusion criteria: Patients that have any other kind of dementia as FTD, PD or LBD; patients with hepatic or renal failure, or diseases that make it impossible to follow the study schedule; patients on antiepileptics or antipsychotics.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alzheimer's dementia, vascular dementia or mixed forms of both according to ICD10 (F00, F01) criteria.
- •The patient is 55 years of age or older.
- •Residents at a nursing home and who have been there for at least 4 weeks prior to inclusion.
- •Signed informed consent by the patient or the relatives signed agreement that they have no reservations against patient's participation in the study.
- •At least one week history of agitation or aggression, score 6 or more in NPI-NH-subscale agitation/aggression.
排除标准
- •Previous intolerability or known hypersensitivity to Oxcarbazepine or its equivalents
- •Low sodium serum levels <135 mmol/L
- •Severe impaired renal function (creatinine clearance <30 ml/min, calculated with Cockroft + Gault's formula)
- •Hepatic failure (transaminases (g-GT and ALAT > 3 times upper normal limit).
- •Patients with AV-block II and III and all kinds of arrhythmia necessitating a treatment.
- •Severe somatic diseases that afford a change of medication and will compromise the attendance to the study.
- •Patients on cyclosporine.
- •Patients in need of strong analgesics like opioids as codeines
- •Patients taking carisoprodol
- •Alcohol or drug abuse during the last 12 months (used a higher dosage than prescribed)
- •The patient has been on ChEIs or memantine for less than 3 months or any change in the dosage during the last 2 weeks.
- •The patient is taking antiepileptics or antipsychotics (may be included two weeks after the use of antipsychotics has been ended).
- •The patient is taking MAOI or lithium
- •The patient with a dementia of type PDD, FTD or DLB
- •The patients with a severe or acute neurological disease (e.g. epilepsy, acute CVE, severe Parkinson's disease, acute confusion) or a severe psychiatric disorder like bipolar disorder, schizophrenia...
- •The patients who have participated in another clinical trial during the last 3 months.
- •The patients who have been randomized to the same study before.
结局指标
主要结局
Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version)
次要结局
- Reduction in aggression as measured by BARS (Behavior Agitation Rating Scale),
- Reduction in the burden to health-care personnel as measured by NPI-NH.
- Evaluate the concomitant use of acute medication (haloperidol), and compare the frequency and dosage used in the two groups.