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| Sponsor: | Tuscaloosa Research & Education Advancement Corporation |
|---|---|
| Collaborator: |
Abbott |
| Information provided by: | Tuscaloosa Research & Education Advancement Corporation |
| ClinicalTrials.gov Identifier: | NCT00315900 |
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00315900 History of Changes |
| Other Study ID Numbers: | TREAC00081, 06-13 Station number |
| Study First Received: | April 17, 2006 |
| Last Updated: | March 16, 2007 |
| Health Authority: | United States: Institutional Review Board |
|
Seroquel Depakote ER Nursing Home |
Quetiapine Divalproex ER Agitation |
|
Dementia Psychomotor Agitation Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations Signs and Symptoms Valproic Acid Quetiapine |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Antipsychotic Agents |