Agitation Aggression in DementiaPhase 3NCT00145691
The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)
A Phase 3 study testing Oxcarbazepine in people with Agitation Aggression in Dementia, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Agitation Aggression in Dementia
- What is being tested?
- Oxcarbazepine
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2005to Oct 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Agitation Aggression in Dementia
- Being tested
- Oxcarbazepine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxcarbazepineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startSep 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Agitation Aggression in DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Investigators
- Oskar H Sommer, MD, Principal investigator, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145691
- Sponsor's protocol ID
- EudraCT number: 2004-005266-20
- Other IDs
- Sponsor's Protocol Code: 1500
- Status last verified
- Mar 2007
- First submitted
- 1 Sep 2005
- Last updated
- 21 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19182483
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00145691
- Acronym / sponsor ID
- EudraCT number: 2004-005266-20
- Conditions
- Agitation Aggression in Dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Oct 2006 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxcarbazepine | Drug | – |
Primary outcome
Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version)
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2007.
- Derived from this study: PubMed 19182483Sommer 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.
Related trials for Agitation Aggression in Dementia
Not yet recruitingPhase 2
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
Aggressive Behavior in Fragile X Syndome
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
Active, not recruitingPhase 2
Clinical Trial on Agitation in Alzheimer's Dementia
Alzheimer Disease, Agitation,Psychomotor
Not yet recruiting
Effect of Verbal De-Escalation-Based Simulation on Agitation Management, Perception of Aggression, and Impact of Aggression in Emergency Department Nurses
Agitation Management, Aggression
RecruitingPhase 2
Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.
Alzheimer Disease, Agitation in Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oskar H Sommer, MD principal investigator
Sykehuset Innlandet HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxcarbazepine in people with Agitation Aggression in Dementia, run by Sykehuset Innlandet HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in aggression and agitation as measured by means of NPI-NH-subscale agitation / aggression (Neuropsychiatric Inventory, Nursing Home Version). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00145691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2007.