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

NCT00315900 | Terminated Phase 3 FDA Drug

• 2 other identifiers: TREAC0008106-13 Station number
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitation; Dementia

Keywords

Seroquel; Depakote ER; Nursing Home; Quetiapine; Divalproex ER; Agitation

Outcome Measures

Primary Outcomes (1)

• Cohen-Mansfield Agitation Inventory (CMAI)

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

  12 week

Secondary Outcomes (1)

• Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD)

  12 weeks

Study Arms (2)

Depakote ER

EXPERIMENTAL

Depakote ER

Drug: Depakote ER

Seroquel

ACTIVE COMPARATOR

Seroquel

Drug: Seroquel

Interventions

Depakote ER DRUG

depakote ER

Also known as: Divalproex

Depakote ER

Seroquel DRUG

seroquel

Also known as: quetiapine

Seroquel

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Tuscaloosa Research & Education Advancement Corporation: lead
• Abbott: collaborator

Study Sites (1)

Tuscaloosa VA Medical Center

Tuscaloosa, Alabama, 35404, United States

Location

Related Publications (1)

• Shuster JL Jr. Palliative care for advanced dementia. Clin Geriatr Med. 2000 May;16(2):373-86. doi: 10.1016/s0749-0690(05)70062-8.

  PMID: 10783434 BACKGROUND

MeSH Terms

Conditions

Psychomotor Agitation; Dementia

Interventions

Valproic Acid; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John L Shuster, MD

  Tuscaloosa Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Staff for Research

Study Record Dates

• First Submitted: April 17, 2006
• First Posted: April 19, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: February 28, 2008
• Last Updated: April 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)