Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145691
Status:
COMPLETED
Last Update Posted:
2007-03-21
First Post:
2005-09-01
Brief Title:
The Effect of Oxcarbazepine in the Treatment of Agitation Aggression in Dementia OBAD
Sponsor:
Sykehuset Innlandet HF
Organization:
Sykehuset Innlandet HF
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We intend to conduct a phase III b trial to verify Oxcarbazepines 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 Scaleand reduction in the burden to health-care personnel as measured by NPI-NH
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 Scaleand 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 Alzheimers 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Sponsors Protocol Code 1500 | None | None | None |