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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier:
NCT00315900
First received: April 17, 2006
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  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 (Subject, Caregiver, Investigator, Outcomes Assessor)
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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). [ Time Frame: 12 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: May 2006
Study Completion Date: March 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Depakote ER
Depakote ER
 Drug: Depakote ER
depakote ER
Other Name: Divalproex
Active Comparator: Seroquel
Seroquel
 Drug: Seroquel
seroquel
Other Name: quetiapine

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

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

Publications:

Responsible Party: Lori Davis, MD, ACOS research, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00315900     History of Changes
Other Study ID Numbers: TREAC00081, 06-13 Station number
Study First Received: April 17, 2006
Last Updated: August 30, 2012
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 16, 2013