The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sykehuset Innlandet HF
• Treatments: Carbamazepine; Oxcarbazepine

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.