Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315900
Status:
TERMINATED
Last Update Posted:
2017-04-27
First Post:
2006-04-17
Brief Title:
Depakote Extended Release ER Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
Sponsor:
Tuscaloosa Research Education Advancement Corporation
Organization:
Tuscaloosa Research Education Advancement Corporation
Study Overview
Official Title:
Depakote ER vs Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator closed study and left VAMC
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 mcgmL 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 Alzheimers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-13 Station number | OTHER | Tuscaloosa VA IRB | None |