drugset / Trial / NCT00315900

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

NCT00315900

RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2006-05-01
Primary completion
2007-12-01
Completion
2008-02-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Quetiapine Small molecule 25 mg
Subject Valproate Small molecule 250 mg

Indications