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

Primary Purpose

Agitation, Dementia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Depakote ER
Seroquel
Sponsored by
Tuscaloosa Research & Education Advancement Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation focused on measuring Seroquel, Depakote ER, Nursing Home, Quetiapine, Divalproex ER, Agitation

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tuscaloosa VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Depakote ER

Seroquel

Arm Description

Depakote ER

Seroquel

Outcomes

Primary Outcome Measures

Cohen-Mansfield Agitation Inventory (CMAI)
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)
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).

Full Information

First Posted
April 17, 2006
Last Updated
April 25, 2017
Sponsor
Tuscaloosa Research & Education Advancement Corporation
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00315900
Brief Title
Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
Official Title
Depakote ER vs. Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Investigator closed study and left VAMC.
Study Start Date
May 1, 2006 (Actual)
Primary Completion Date
December 1, 2007 (Actual)
Study Completion Date
February 28, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tuscaloosa Research & Education Advancement Corporation
Collaborators
Abbott

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation, Dementia
Keywords
Seroquel, Depakote ER, Nursing Home, Quetiapine, Divalproex ER, Agitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Depakote ER
Arm Type
Experimental
Arm Description
Depakote ER
Arm Title
Seroquel
Arm Type
Active Comparator
Arm Description
Seroquel
Intervention Type
Drug
Intervention Name(s)
Depakote ER
Other Intervention Name(s)
Divalproex
Intervention Description
depakote ER
Intervention Type
Drug
Intervention Name(s)
Seroquel
Other Intervention Name(s)
quetiapine
Intervention Description
seroquel
Primary Outcome Measure Information:
Title
Cohen-Mansfield Agitation Inventory (CMAI)
Description
Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to systematically assess agitation (higher is more severe).
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Behavioral Pathology in Alzheimer's Disease Rating Scale (BEHAVE-AD)
Description
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).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John L Shuster, MD
Organizational Affiliation
Tuscaloosa Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuscaloosa VA Medical Center
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10783434
Citation
Shuster JL Jr. Palliative care for advanced dementia. Clin Geriatr Med. 2000 May;16(2):373-86. doi: 10.1016/s0749-0690(05)70062-8.
Results Reference
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Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia

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