Status:
TERMINATED
Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
Lead Sponsor:
Tuscaloosa Research & Education Advancement Corporation
Collaborating Sponsors:
Abbott
Conditions:
Agitation
Dementia
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to assess the relative efficacy of Depakote ER and Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a Department of Veterans A...
Detailed Description
This study is a prospective, single-center, randomized, double-blind, double-dummy, crossover trial of Depakote ER vs. Seroquel for agitated behaviors among veterans with dementia. After consent is ob...
Eligibility Criteria
Inclusion
- Veterans
- Males or females
- Aged 55 or older
- With a diagnosis of dementia (either Alzheimer's disease, vascular dementia, or mixed Alzheimer's and vascular dementia)
- Residing in a Tuscaloosa VA Medical Center (TVAMC) NHCU bed
- Admitted to a NHCU bed at Tuscaloosa VA Medical Center
- Score of \> 5 on the Functional Assessment Staging (FAST) scale
- Score of \< 23 on the Mini-Mental State Examination
- Score of \> 1 on the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) global rating
- Total BEHAVE-AD score of \> 8
- Agitation present (by history or chart review) for at least two weeks (to minimize chance of enrolling for agitation due to delirium).
Exclusion
- Diagnosis of dementia caused by a condition other than either Alzheimer's disease, vascular dementia, or mixed Alzheimer's and vascular dementia
- History of schizophrenia, bipolar disorder, or schizoaffective disorder
- Untreated depressive or anxiety disorder
- Untreated pain evident on physical examination
- Known allergy or hypersensitivity to either study drug
- History of epilepsy or seizures
- Diagnosis of liver disease or significant abnormalities on liver function tests
- Thrombocytopenia
- Diagnosis or past history of pancreatitis
- Past history of neuroleptic malignant syndrome
- Co-morbid condition that would render tapering off of current antipsychotics or anticonvulsants unsafe
- History of agitation unresponsive to an adequate previous trial of either valproate or quetiapine
- The patient has no identifiable guardian, decision-making proxy, or next of kin to approach for consent to participate.
- The patient's guardian, decision-making proxy, or next of kin withholds, or does not grant, consent to participate
- Patient judged to be too ill to participate
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00315900
Start Date
May 1 2006
End Date
February 28 2008
Last Update
April 27 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, United States, 35404