Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia (SFBRI)
This study has been terminated.
(Recruitment was too difficult)
First Posted: September 21, 2005
Last Update Posted: September 7, 2011
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SAM Technology & The San Francisco Brain Research Institute
Information provided by (Responsible Party):
James C. Patterson, II, MD. Ph, Louisiana State University Health Sciences Center Shreveport
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.
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia, (SFBRI).
Primary Outcome Measures:
- fMRI [ Time Frame: at Week 2 and Week 16 ]
- SAM-BFT + cognitive tests [ Time Frame: at Week 3 and Week 16 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2006 (Final data collection date for primary outcome measure)
10-15 mg daily; if needed dosage may be increased to 30 mg daily after 2 weeks; maintenance 15 mg/day, periodically reassessed.
Other Name: Abilify
- 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 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 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 don't 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.