- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00315900
Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
April 25, 2017 updated by: Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
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.
Study Overview
Status
Terminated
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Tuscaloosa, Alabama, United States, 35404
- Tuscaloosa VA Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Depakote ER
|
depakote ER
Other Names:
|
ACTIVE_COMPARATOR: Seroquel
|
seroquel
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John L Shuster, MD, Tuscaloosa Veterans Affairs Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2006
Primary Completion (ACTUAL)
December 1, 2007
Study Completion (ACTUAL)
February 28, 2008
Study Registration Dates
First Submitted
April 17, 2006
First Submitted That Met QC Criteria
April 17, 2006
First Posted (ESTIMATE)
April 19, 2006
Study Record Updates
Last Update Posted (ACTUAL)
April 27, 2017
Last Update Submitted That Met QC Criteria
April 25, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Dyskinesias
- Psychomotor Disorders
- Psychomotor Agitation
- Dementia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Valproic Acid
- Quetiapine Fumarate
Other Study ID Numbers
- TREAC00081
- 06-13 Station number (OTHER: Tuscaloosa VA IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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