The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)
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|ClinicalTrials.gov Identifier: NCT00145691|
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : March 21, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Agitation Aggression in Dementia||Drug: Oxcarbazepine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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 Center Trial. A Phase III Study|
|Study Start Date :||September 2005|
|Study Completion Date :||October 2006|
- Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145691
|Sykehuset Innlandet HF|
|Reinsvoll, Oppland, Norway, 2840|
|Principal Investigator:||Oskar H Sommer, MD||Sykehuset Innlandet HF|