Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211380
Status:
TERMINATED
Last Update Posted:
2011-09-07
First Post:
2005-09-13
Brief Title:
Cognitive Improvement With Aripiprazole Abilify in Patients With Schizophrenia SFBRI
Sponsor:
Louisiana State University Health Sciences Center Shreveport
Organization:
Louisiana State University Health Sciences Center Shreveport
Study Overview
Official Title:
Cognitive Improvement With Aripiprazole Abilify in Patients With Schizophrenia SFBRI
Status:
TERMINATED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment was too difficult
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is the sister study to the BMS Cognitive Improvement with Aripiprazole Abilify study LSUHSC H04-022 Evaluation of cognitive ability in patients with schizophrenia or schizoaffective disorder both before and after a switch from risperidone olanzapine or risperidone Consta injections to aripiprazole may reveal some of the cognitive changes that correlate with the improved response better side effect profile and effects on other components of the negative symptom array Further examination of brain functional activity using functional magnetic resonance imaging fMRI during an episodic memory task as well as behavioral performance and associated electroencephalographic EEG data of working memory and intermediate term verbal memory collected with the Sustained Attention and Memory Brain Function Test SAM-BFT may also provide data showing the neural correlates of these changes in cognition
Detailed Description:
Our long-range goal is to understand how the schizophrenic brain is abnormal as well as how the function of the brain changes in response to antipsychotic medication to better understand and effectively treat disorders with these drugs This information can be used in other disorders as well as there are many psychiatric disorders that are targeted by the newer atypical antipsychotics
The objective of this application which is the next step in pursuit of our long-range goal is to compare response on a series of cognitive tests verbal learning working memory and attention and changes in brain activity in a group of patients with schizophrenia or schizoaffective disorder who are taking risperidone olanzapine or risperidone Consta injections and who switch to aripiprazole and in a group of normal control subjects evaluated twice to control for learning effects
The central hypothesis of this application is that patients with schizophrenia or schizoaffective disorder that are taking aripiprazole will have improvements in cognition consistent with the medications efficacy We expect that changes in brain activity from fMRI and EEG will be correlated with this improvement as determined by performance on cognitive tests Further changes in regional connectivity of affected brain regions will reflect these specific cognitive changes related to aripiprazole
The rationale for this proposed study is that once we have a better understanding of which drugs improve cognition and what brain regions respond differentially to aripiprazole and risperidone olanzapine or risperidone Consta we will have a better understanding of the functional differences tied to the differential actions of the drugs This is important because we really dont understand how these medications affect cognition We are especially well suited to undertake the proposed research as we have access to a large population of patients with schizophrenia or schizoaffective disorder here at our institution
The objective of this application which is the next step in pursuit of our long-range goal is to compare response on a series of cognitive tests verbal learning working memory and attention and changes in brain activity in a group of patients with schizophrenia or schizoaffective disorder who are taking risperidone olanzapine or risperidone Consta injections and who switch to aripiprazole and in a group of normal control subjects evaluated twice to control for learning effects
The central hypothesis of this application is that patients with schizophrenia or schizoaffective disorder that are taking aripiprazole will have improvements in cognition consistent with the medications efficacy We expect that changes in brain activity from fMRI and EEG will be correlated with this improvement as determined by performance on cognitive tests Further changes in regional connectivity of affected brain regions will reflect these specific cognitive changes related to aripiprazole
The rationale for this proposed study is that once we have a better understanding of which drugs improve cognition and what brain regions respond differentially to aripiprazole and risperidone olanzapine or risperidone Consta we will have a better understanding of the functional differences tied to the differential actions of the drugs This is important because we really dont understand how these medications affect cognition We are especially well suited to undertake the proposed research as we have access to a large population of patients with schizophrenia or schizoaffective disorder here at our institution
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