Clinical Trial: The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD) - An Eight Week Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi
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 Summary:
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.
Sponsor: Sykehuset Innlandet HF
Current Primary Outcome: Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
Original Secondary Outcome: Same as current
Information By: Sykehuset Innlandet HF
Dates:
Date Received: September 1, 2005
Date Started: September 2005
Date Completion:
Last Updated: March 20, 2007
Last Verified: March 2007