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| ID | Type | Description | Link |
|---|---|---|---|
| 06-13 Station number | Other Identifier | Tuscaloosa VA IRB |
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Investigator closed study and left VAMC.
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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depakote ER | Experimental | Depakote ER |
|
| Seroquel | Active Comparator | Seroquel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depakote ER | Drug | depakote ER |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohen-Mansfield Agitation Inventory (CMAI) | Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to systematically assess agitation (higher is more severe). | 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John L Shuster, MD | Tuscaloosa Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuscaloosa VA Medical Center | Tuscaloosa | Alabama | 35404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10783434 | Background | 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. |
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Seroquel | Drug | seroquel |
|
|
| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |