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

NCT00145691 | Completed Phase 3 DMC

• 2 other identifiers: EudraCT number: 2004-005266-20Sponsor's Protocol Code: 1500
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Agitation Aggression in Dementia

Outcome Measures

Primary Outcomes (1)

• Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version)

Secondary Outcomes (3)

• Reduction in aggression as measured by BARS (Behavior Agitation Rating Scale),

• Reduction in the burden to health-care personnel as measured by NPI-NH.

• Evaluate the concomitant use of acute medication (haloperidol), and compare the frequency and dosage used in the two groups.

Interventions

Oxcarbazepine DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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...

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead

Study Sites (1)

Sykehuset Innlandet HF

Reinsvoll, Oppland, 2840, Norway

Location

Related Publications (1)

• Sommer OH, Aga O, Cvancarova M, Olsen IC, Selbaek G, Engedal K. Effect of oxcarbazepine in the treatment of agitation and aggression in severe dementia. Dement Geriatr Cogn Disord. 2009;27(2):155-63. doi: 10.1159/000199236. Epub 2009 Feb 2.

  PMID: 19182483 DERIVED

MeSH Terms

Interventions

Oxcarbazepine

Intervention Hierarchy (Ancestors)

Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Oskar H Sommer, MD

  Sykehuset Innlandet HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: September 1, 2005
• Study Completion: October 1, 2006
• Last Updated: March 21, 2007

Record last verified: 2007-03

Locations

NO (1)