Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-28 @ 2:08 PM
Study NCT ID:
NCT00211302
Status:
TERMINATED
Last Update Posted:
2011-09-07
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia (BMS)
Sponsor:
Louisiana State University Health Sciences Center Shreveport
Organization:
Study Overview
Official Title:
Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia. (BMS)
Status:
TERMINATED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment too difficult
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluation of cognitive ability in patients with schizophrenia or schizoaffective disorder both before and after a switch from risperidone 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 a verbal learning task, as well as behavioral performance and associated electroencephalographic (EEG) data of episodic memory, 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:
* 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 disorder 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 the 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 medication's 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 differently 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 don't understand how these medications affect cognition.
* The objective of this application, which is the next step in pursuit of the 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 medication's 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 differently 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 don't understand how these medications affect cognition.
Study Oversight
Has Oversight DMC:
False
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?: