Agitation Aggression in Dementia Clinical Trial
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
| Verified date | March 2007 |
| Source | Sykehuset Innlandet HF |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Norway: Norwegian Medicines Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | October 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 55 Years and older |
| Eligibility |
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) - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Norway | Sykehuset Innlandet HF | Reinsvoll | Oppland |
| Lead Sponsor | Collaborator |
|---|---|
| Sykehuset Innlandet HF |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version) | |||
| Secondary | Reduction in aggression as measured by BARS (Behavior Agitation Rating Scale), | |||
| Secondary | Reduction in the burden to health-care personnel as measured by NPI-NH. | |||
| Secondary | Evaluate the concomitant use of acute medication (haloperidol), and compare the frequency and dosage used in the two groups. |