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| Sponsor: | Sykehuset Innlandet HF |
|---|---|
| Information provided by: | Sykehuset Innlandet HF |
| ClinicalTrials.gov Identifier: | NCT00145691 |
Purpose
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 |
|---|---|---|
|
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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 History of Changes |
| Health Authority: | Norway: Norwegian Medicines Agency |
|
Physiological Effects of Drugs Psychotropic Drugs Psychomotor Agitation Brain Diseases Signs and Symptoms Mental Disorders Sensory System Agents Therapeutic Uses Psychomotor Disorders Analgesics Dementia Aggression Neurobehavioral Manifestations Tranquilizing Agents Oxcarbazepine |
Nervous System Diseases Central Nervous System Depressants Central Nervous System Diseases Antimanic Agents Dyskinesias Pharmacologic Actions Behavioral Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Carbamazepine Analgesics, Non-Narcotic Neurologic Manifestations Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |