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

Primary Purpose

Agitation Aggression in Dementia

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Oxcarbazepine
Sponsored by
Sykehuset Innlandet HF
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation Aggression in Dementia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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) 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.

Sites / Locations

  • Sykehuset Innlandet HF

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 1, 2005
Last Updated
March 20, 2007
Sponsor
Sykehuset Innlandet HF
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1. Study Identification

Unique Protocol Identification Number
NCT00145691
Brief Title
The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sykehuset Innlandet HF

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation Aggression in Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Oxcarbazepine
Primary Outcome Measure Information:
Title
Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version)
Secondary Outcome Measure Information:
Title
Reduction in aggression as measured by BARS (Behavior Agitation Rating Scale),
Title
Reduction in the burden to health-care personnel as measured by NPI-NH.
Title
Evaluate the concomitant use of acute medication (haloperidol), and compare the frequency and dosage used in the two groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oskar H Sommer, MD
Organizational Affiliation
Sykehuset Innlandet HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset Innlandet HF
City
Reinsvoll
State/Province
Oppland
ZIP/Postal Code
2840
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
19182483
Citation
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.
Results Reference
derived

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

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