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

March 20, 2007 updated by: Sykehuset Innlandet HF

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Oppland
      • Reinsvoll, Oppland, Norway, 2840
        • Sykehuset Innlandet HF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Innlandet HF

Investigators

  • Principal Investigator: Oskar H Sommer, MD, Sykehuset Innlandet HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

March 21, 2007

Last Update Submitted That Met QC Criteria

March 20, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT number: 2004-005266-20
  • Sponsor's Protocol Code: 1500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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