the effect of oxcarbazepine in the treatment of agitation / aggression in dementia (obad)

Conditions: Agitation Aggression in Dementia

Summary: 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.

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.

Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.