Status:
COMPLETED
The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)
Lead Sponsor:
Sykehuset Innlandet HF
Conditions:
Agitation Aggression in Dementia
Eligibility:
All Genders
55+ years
Phase:
PHASE3
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...
Detailed Description
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 f...
Eligibility Criteria
Inclusion
- Alzheimer's dementia, vascular dementia or mixed forms of both according to ICD10 (F00, F01) criteria.
- The patient is 55 years of age or older.
- Residents at a nursing home and who have been there for at least 4 weeks prior to inclusion.
- Signed informed consent by the patient or the relatives signed agreement that they have no reservations against patient's participation in the study.
- At least one week history of agitation or aggression, score 6 or more in NPI-NH-subscale agitation/aggression.
Exclusion
- Previous intolerability or known hypersensitivity to Oxcarbazepine or its equivalents
- Low sodium serum levels \<135 mmol/L
- Severe impaired renal function (creatinine clearance \<30 ml/min, calculated with Cockroft + Gault's formula)
- Hepatic failure (transaminases (g-GT and ALAT \> 3 times upper normal limit).
- Patients with AV-block II and III and all kinds of arrhythmia necessitating a treatment.
- Severe somatic diseases that afford a change of medication and will compromise the attendance to the study.
- Patients on cyclosporine.
- Patients in need of strong analgesics like opioids as codeines
- Patients taking carisoprodol
- Alcohol or drug abuse during the last 12 months (used a higher dosage than prescribed)
- The patient has been on ChEIs or memantine for less than 3 months or any change in the dosage during the last 2 weeks.
- The patient is taking antiepileptics or antipsychotics (may be included two weeks after the use of antipsychotics has been ended).
- The patient is taking MAOI or lithium
- The patient with a dementia of type PDD, FTD or DLB
- The patients with a severe or acute neurological disease (e.g. epilepsy, acute CVE, severe Parkinson's disease, acute confusion) or a severe psychiatric disorder like bipolar disorder, schizophrenia...
- The patients who have participated in another clinical trial during the last 3 months.
- The patients who have been randomized to the same study before.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00145691
Start Date
September 1 2005
End Date
October 1 2006
Last Update
March 21 2007
Active Locations (1)
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1
Sykehuset Innlandet HF
Reinsvoll, Oppland, Norway, 2840