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

This study has been completed.
Sponsor:
Information provided by:
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT00145691
First received: September 1, 2005
Last updated: March 20, 2007
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Agitation Aggression in Dementia
Drug: Oxcarbazepine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sykehuset Innlandet HF:

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.

Estimated Enrollment: 100
Study Start Date: September 2005
Study Completion Date: October 2006
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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00145691

Locations
Norway
Sykehuset Innlandet HF
Reinsvoll, Oppland, Norway, 2840
Sponsors and Collaborators
Sykehuset Innlandet HF
Investigators
Principal Investigator: Oskar H Sommer, MD Sykehuset Innlandet HF
  More Information

No publications provided by Sykehuset Innlandet HF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00145691     History of Changes
Other Study ID Numbers: EudraCT number: 2004-005266-20, Sponsor’s Protocol Code: 1500
Study First Received: September 1, 2005
Last Updated: March 20, 2007
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Aggression
Dementia
Psychomotor Agitation
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Oxcarbazepine
Carbamazepine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014