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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 terminated.
(Investigator closed study and left VAMC.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00315900
First Posted: April 19, 2006
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott
Information provided by (Responsible Party):
Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation:

Primary Outcome Measures:
  • Cohen-Mansfield Agitation Inventory (CMAI) [ Time Frame: 12 week ]
    Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to systematically assess agitation (higher is more severe).


Secondary Outcome Measures:
  • Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD) [ Time Frame: 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).


Enrollment: 20
Actual Study Start Date: May 1, 2006
Study Completion Date: February 28, 2008
Primary Completion Date: December 1, 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Associate Chief of Staff for Research, Tuscaloosa Research & Education Advancement Corporation
ClinicalTrials.gov Identifier: NCT00315900     History of Changes
Other Study ID Numbers: TREAC00081
06-13 Station number ( Other Identifier: Tuscaloosa VA IRB )
First Submitted: April 17, 2006
First Posted: April 19, 2006
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Lori Davis, MD, 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
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Quetiapine Fumarate
Valproic Acid
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents


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