Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia

• Status: Terminated
• Trial end date: 2008-02-28
• Target enrollment: 0
• Participant gender: All

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 Affairs (VA) nursing home care unit (NHCU). The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population. The primary hypothesis is that agitated dementia patients will demonstrate a significantly greater reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores while treated with Depakote ER compared to treatment with Seroquel.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuscaloosa Research & Education Advancement Corporation
• Collaborator: Abbott
• Treatments: Quetiapine Fumarate; Valproic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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