Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia (BMS)
|ClinicalTrials.gov Identifier: NCT00211302|
Recruitment Status : Terminated (Enrollment too difficult)
First Posted : September 21, 2005
Last Update Posted : September 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Drug: aripiprazole||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Improvement With Aripiprazole (Abilify) in Patients With Schizophrenia. (BMS)|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||February 2006|
|Actual Study Completion Date :||February 2006|
- fMRI [ Time Frame: at Week 2 and Week 16 ]
- SAM-BFT + cognitive tests [ Time Frame: at Week 3 and Week 16 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211302
|United States, Louisiana|
|Psychopharmacology Research Clinic|
|Shreveport, Louisiana, United States, 71103|
|Principal Investigator:||James C Patterson, MD, PhD||LSU Health Sciences Center-Shreveport/Department of Psychiatry|