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| ID | Type | Description | Link |
|---|---|---|---|
| Sponsor's Protocol Code: 1500 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxcarbazepine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oskar H Sommer, MD | Sykehuset Innlandet HF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sykehuset Innlandet HF | Reinsvoll | Oppland | 2840 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19182483 | Derived | Sommer OH, Aga O, Cvancarova M, Olsen IC, Selbaek G, Engedal K. Effect of oxcarbazepine in the treatment of agitation and aggression in severe dementia. Dement Geriatr Cogn Disord. 2009;27(2):155-63. doi: 10.1159/000199236. Epub 2009 Feb 2. |
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| ID | Term |
|---|---|
| D000078330 | Oxcarbazepine |
| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| D006571 | Heterocyclic Compounds |