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The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)

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

NCT00145691•Sykehuset Innlandet HF

View on ClinicalTrials.gov

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 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.

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 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

Age

55 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 Criteria

•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)
+7 more criteria

Locations (1)

Sykehuset Innlandet HF

Reinsvoll, Oppland, Norway

Key Dates

Start Date

September 1, 2005

Completion Date

October 1, 2006

Last Updated

March 21, 2007

Enrollment

100

Estimated participants

Conditions

Agitation Aggression in Dementia

Interventions

Oxcarbazepine

DRUG