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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Agitation Aggression in Dementia
- Sponsor
- Sykehuset Innlandet HF
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version)
- Status
- Completed
- Last Updated
- 19 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
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)
Outcomes
Primary Outcomes
Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version)
Secondary Outcomes
- 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.