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

Tuscaloosa Research & Education Advancement Corporation

Status and phase

Terminated

Phase 3

Conditions

Agitation

Dementia

Treatments

Drug: Depakote ER

Drug: Seroquel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00315900

TREAC00081

06-13 Station number (Other Identifier)

Details and patient eligibility

About

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.

Full 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 obtained and after a washout period of one week or five half-lives after taper (if necessary), 20 eligible patients will be randomized to received one of two treatments. The first is DEPAKOTE ER, initiated at 250 mg daily. The other treatment will be Seroquel, starting at 25 mg BID. Both treatments will be co-administered with a placebo that matches the other drug (to preserve blinding). Using serial examinations and blinded laboratory reporting, doses will be adjusted to clinical response or to achieve a serum valproate level of at least 50 mcg/mL. After a treatment period of six weeks, patients will be crossed over to the other treatment without washout (doses will be adjusted concurrently) for a second six-week treatment period. The Cohen-Mansfield Agitation Inventory (CMAI) will be the primary outcome measure. Secondary measures include the Behavior Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD); Clinical Global Impression Scale - Severity; Clinical Global Impression Scale - Improvement; Barnes Akathisia Scale (BAS); and the Abnormal Involuntary Movements Scale (AIMS). Outcome measures will be performed at the end of each six-week treatment period to avoid carryover effects.

Enrollment

20 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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