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Sponsored by: |
Sykehuset Innlandet HF |
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Information provided by: | Sykehuset Innlandet HF |
ClinicalTrials.gov Identifier: | NCT00145691 |
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 | Intervention | Phase |
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Agitation Aggression in Dementia |
Drug: Oxcarbazepine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | September 2005 |
Study Completion Date: | October 2006 |
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.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | EudraCT number: 2004-005266-20, Sponsor’s Protocol Code: 1500 |
Study First Received: | September 1, 2005 |
Last Updated: | March 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00145691 |
Health Authority: | Norway: Norwegian Medicines Agency |
Oxcarbazepine Central Nervous System Diseases Psychomotor Agitation Brain Diseases Dyskinesias Cognition Disorders Behavioral Symptoms Signs and Symptoms |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurologic Manifestations Dementia Aggression Neurobehavioral Manifestations Delirium |
Therapeutic Uses Nervous System Diseases Psychomotor Disorders |
Central Nervous System Agents Pharmacologic Actions Anticonvulsants |