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

Phase 3

Terminated

• Conditions: Agitation; Dementia
• Interventions: Drug: Seroquel; Drug: Depakote ER

• Registration Number: NCT00315900
• Lead Sponsor: Tuscaloosa Research & Education Advancement Corporation

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 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.

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 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.

Study Timeline

• Study First Submitted: 2006-04-17
• Study First Submitted QC: 2006-04-17
• Study First Posted: 2006-04-19
• Study Start: 2006-05-01
• Primary Completion: 2007-12-01
• Study Completion: 2008-02-28
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Seroquel	Seroquel	Seroquel
Depakote ER	Depakote ER	Depakote ER

Primary Outcome Measures

Name	Time	Method
Cohen-Mansfield Agitation Inventory (CMAI)	12 week	Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to systematically assess agitation (higher is more severe).

Secondary Outcome Measures

Name	Time	Method
Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD)	12 weeks	A psychiatric rating scale to evaluate behavioral disturbances in dementia patients. assesses 25 potentially remediable behavioral symptoms on a 4-rating-point severity scale (higher score is more severe).

Trial Locations

Locations (1)

Tuscaloosa VA Medical Center; 🇺🇸 Tuscaloosa, Alabama, United States