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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:
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: April 25, 2017
Last verified: April 2017
April 17, 2006
April 25, 2017
May 1, 2006
December 1, 2007   (Final data collection date for primary outcome measure)
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).
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).
Complete list of historical versions of study NCT00315900 on ClinicalTrials.gov Archive Site
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).
The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population
Not Provided
Not Provided
 
Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
Depakote ER vs. Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
  • Agitation
  • Dementia
  • Drug: Depakote ER
    depakote ER
    Other Name: Divalproex
  • Drug: Seroquel
    seroquel
    Other Name: quetiapine
  • Experimental: Depakote ER
    Depakote ER
    Intervention: Drug: Depakote ER
  • Active Comparator: Seroquel
    Seroquel
    Intervention: Drug: Seroquel
Shuster JL Jr. Palliative care for advanced dementia. Clin Geriatr Med. 2000 May;16(2):373-86. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
February 28, 2008
December 1, 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00315900
TREAC00081
06-13 Station number ( Other Identifier: Tuscaloosa VA IRB )
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
Plan to Share IPD: No
Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
Tuscaloosa Research & Education Advancement Corporation
Abbott
Principal Investigator: John L Shuster, MD Tuscaloosa VA Medical Center
Tuscaloosa Research & Education Advancement Corporation
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP