Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208819
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2005-09-13
Brief Title:
A Comparison of Two Standard Therapies in the Management of Dementia With Agitation
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Randomized Comparison of Monotherapy Risperidone Quetiapine or Olanzapine Versus Combination Therapy Risperidone Quetiapine or Olanzapine Divalproexin the Management of Dementia With Agitation A Pilot Comparison of Two Standard Therapies
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether an antipsychotic medication alone or an antipsychotic medication in combination with divalproex is the most effective and safest way to treat agitation in elderly patients with dementia
Detailed Description:
Previous researchers have attempted to establish a target dose for antipsychotic medications such as risperidone quetiapine or olanzapine in treating symptoms of agitation in dementia They have tried to identify the dose with the best risk-benefit ratio for patients considering the significant side effects the medications can cause Patients taking the doses identified respond only partially and continue to experience some symptoms of agitation however One study showed that in patients whose agitation symptoms were not adequately controlled by the target dose of an antipsychotic medication alone the addition of divalproex further improved behavior in 72 of patients
The goal of this study is to compare two standard therapies for the management of agitation symptoms in dementia patients Subjects in this study will include patients who are admitted to the Wesley Woods Inpatient service for the treatment for dementia complicated by behavioral symptoms After a patient reaches the target dose of risperidone up to 15 mgday quetiapine up to 175 mgday or olanzapine up to 75 mgday and agitation symptoms are still not adequately managed he or she will be randomized to one of two groups Group 1 participants will continue to receive increasing doses of antipsychotic medication until symptoms are controlled or he or she is unable to tolerate the dose Group 2 participants will continue to receive the target dose of antipsychotic medication and also receive increasing doses of divalproex until symptoms are controlled or he or she is unable to tolerate the dose Patients will be evaluated at 4 time points during hospitalization Patients will be evaluated using scales that measure changes in cognition function and behavior Laboratory and ECG results and scales testing for movement disorders will be done to monitor safety The family will then be contacted about 3 months the patients hospitalization to assess current treatment status residential status and health status
The goal of this study is to compare two standard therapies for the management of agitation symptoms in dementia patients Subjects in this study will include patients who are admitted to the Wesley Woods Inpatient service for the treatment for dementia complicated by behavioral symptoms After a patient reaches the target dose of risperidone up to 15 mgday quetiapine up to 175 mgday or olanzapine up to 75 mgday and agitation symptoms are still not adequately managed he or she will be randomized to one of two groups Group 1 participants will continue to receive increasing doses of antipsychotic medication until symptoms are controlled or he or she is unable to tolerate the dose Group 2 participants will continue to receive the target dose of antipsychotic medication and also receive increasing doses of divalproex until symptoms are controlled or he or she is unable to tolerate the dose Patients will be evaluated at 4 time points during hospitalization Patients will be evaluated using scales that measure changes in cognition function and behavior Laboratory and ECG results and scales testing for movement disorders will be done to monitor safety The family will then be contacted about 3 months the patients hospitalization to assess current treatment status residential status and health status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None