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Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
This study is currently recruiting participants.
Verified by Tuscaloosa Research & Education Advancement Corporation, March 2007
Sponsors and Collaborators: Tuscaloosa Research & Education Advancement Corporation
Abbott
Information provided by: Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00315900
  Purpose

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.


Condition Intervention Phase
Agitation
Dementia
Drug: Depakote ER
Drug: Seroquel
Phase III

MedlinePlus related topics: Dementia Nursing Homes
Drug Information available for: Divalproex sodium Valproate Sodium Valproic acid Quetiapine Quetiapine fumarate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Depakote ER vs. Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia

Further study details as provided by Tuscaloosa Research & Education Advancement Corporation:

Primary Outcome Measures:
  • 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 VA nursing home care unit (NHCU).

Secondary Outcome Measures:
  • The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population.

Estimated Enrollment: 20
Study Start Date: May 2006
Estimated Study Completion Date: August 2008
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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315900

Contacts
Contact: John L Shuster, MD (205) 554-2000 ext 3627 John.Shuster@med.va.gov

Locations
United States, Alabama
Tuscaloosa VA Medical Center Recruiting
Tuscaloosa, Alabama, United States, 35404
Principal Investigator: John L Shuster, MD            
Sponsors and Collaborators
Tuscaloosa Research & Education Advancement Corporation
Abbott
Investigators
Principal Investigator: John L Shuster, MD Tuscaloosa VA Medical Center
  More Information

Publications:
Study ID Numbers: TREAC00081, 06-13 Station number
Study First Received: April 17, 2006
Last Updated: March 16, 2007
ClinicalTrials.gov Identifier: NCT00315900  
Health Authority: United States: Institutional Review Board

Keywords provided by Tuscaloosa Research & Education Advancement Corporation:
Seroquel
Depakote ER
Nursing Home
Quetiapine
Divalproex ER
Agitation

Study placed in the following topic categories:
Central Nervous System Diseases
Psychomotor Agitation
Brain Diseases
Dyskinesias
Valproic Acid
Cognition Disorders
Signs and Symptoms
Quetiapine
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurologic Manifestations
Dementia
Neurobehavioral Manifestations
Delirium

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Antipsychotic Agents
Antimanic Agents
Pharmacologic Actions
Therapeutic Uses
Psychomotor Disorders
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on January 16, 2009