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Sponsors and Collaborators: |
Tuscaloosa Research & Education Advancement Corporation Abbott |
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Information provided by: | Tuscaloosa Research & Education Advancement Corporation |
ClinicalTrials.gov Identifier: | NCT00315900 |
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 |
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Agitation Dementia |
Drug: Depakote ER Drug: Seroquel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Depakote ER vs. Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia |
Estimated Enrollment: | 20 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | August 2008 |
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.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: John L Shuster, MD | (205) 554-2000 ext 3627 | John.Shuster@med.va.gov |
United States, Alabama | |
Tuscaloosa VA Medical Center | Recruiting |
Tuscaloosa, Alabama, United States, 35404 | |
Principal Investigator: John L Shuster, MD |
Principal Investigator: | John L Shuster, MD | Tuscaloosa VA Medical Center |
Study ID Numbers: | TREAC00081, 06-13 Station number |
Study First Received: | April 17, 2006 |
Last Updated: | March 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00315900 |
Health Authority: | United States: Institutional Review Board |
Seroquel Depakote ER Nursing Home |
Quetiapine Divalproex ER Agitation |
Central Nervous System Diseases Psychomotor Agitation Brain Diseases Dyskinesias Valproic Acid Cognition Disorders Signs and Symptoms |
Quetiapine Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurologic Manifestations Dementia Neurobehavioral Manifestations Delirium |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Enzyme Inhibitors |
Antipsychotic Agents Antimanic Agents Pharmacologic Actions Therapeutic Uses Psychomotor Disorders GABA Agents Central Nervous System Agents Anticonvulsants |