drugset / Trial / NCT00315900
Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
Phase 3
Terminated
20 enrolled
Tuscaloosa Research & Education Advancement Corporation
Abbott · collab
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
Publications
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Quetiapine | Small molecule | 25 mg | — |
| Subject | Valproate | Small molecule | 250 mg | — |