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Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Tuscaloosa Research & Education Advancement Corporation.   Recruitment status was  Recruiting

First Received on April 17, 2006.   Last Updated on March 16, 2007   History of Changes
Sponsor: Tuscaloosa Research & Education Advancement Corporation
Collaborator: 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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Depakote ER vs. Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia

Resource links provided by NLM:


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

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

Additional relevant MeSH terms:
Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Valproic Acid
Quetiapine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipsychotic Agents

ClinicalTrials.gov processed this record on May 24, 2012