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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 6, 2006 | ||||
| Last Updated Date | August 12, 2008 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | August 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
characterize abnormalities in brain structure and function related to schizophrenia [ Time Frame: two scans over a six month period ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
characterize abnormalities in brain structure and function related to schizophrenia | ||||
| Change History | Complete list of historical versions of study NCT00288340 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quantifying Abnormalities in Cortical Activation Associated With Auditory Hallucinations Using Functional Magnetic Resonance Imaging | ||||
| Official Title ICMJE | Quantifying Abnormalities in Cortical Activation Associated With Auditory Hallucinations Using Functional Magnetic Resonance Imaging | ||||
| Brief Summary | The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. The investigators will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment. |
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| Detailed Description | The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. We will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment. We will focus on changes in brain structure and function associated with frequent auditory hallucinations, one of the most disabling manifestations of schizophrenia, and with neuroleptic treatment. In order to address these aims, we will study four groups of subjects:
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Device: functional magnetic resonance imaging | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | August 2006 | ||||
| Primary Completion Date | August 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Investigators will study subjects who:
Normal controls must :
Exclusion Criteria: Subjects and normal controls will be excluded from participation if there is:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00288340 | ||||
| Responsible Party | Adam Anderson, Ph.D., Vanderbilt Medical Center | ||||
| Study ID Numbers ICMJE | 050978, NARSAD | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | National Alliance for Research on Schizophrenia and Depression | ||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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