Schizophrenia Clinical Trial
Official title:
Risperidone Effects On Frontal And Temporal Cortical Function In Schizophrenia Patients Undergoing FMRI Cognitive Task Performance
The general aim is to compare the effects of typical and atypical antipsychotic medication on brain structure and function. A parallel group treatment trial will be utilized to compare the effects of the typical antipsychotic thiothixene versus the atypical antipsychotics risperidone (RIS) and olanzapine (OLZ) on brain structure and function in schizophrenia in an effort to determine the neuroanatomic basis for cognitive pathology in schizophrenia and its amelioration by atypical antipsychotic drugs.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 2007 |
Est. primary completion date | June 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: Inclusion Criteria for Schizophrenia/Schizoaffective Subjects 1. Men and women between ages of 18 to 60 inclusive, of any ethnic origin. 2. Subjects must be right handed. 3. DSM IV criteria for chronic schizophrenia or schizoaffective disorder. 4. Good physical health as determined by complete physical examination, laboratory tests, and EKG Inclusion Criteria for Healthy Control Subjects: 1. Fifteen individuals, matched to the patient subjects on the basis of age, gender, parental SES, handedness. Exclusion Criteria: Exclusion Criteria for Schizophrenia/Schizoaffective Subjects 1. Previous poor response or adverse side effects to thiothixene, olanzapine or risperidone. 2. Left handedness 3. Epilepsy, HIV, or current myeloproliferative disorder 4. Current severe major depression. 5. Current or past history of Substance Dependence (except caffeine or nicotine) 6. Criteria for active Substance Abuse within past 30 days 7. Learning disability 8. Mental Retardation 9. Foreign metal objects or implants as determined by MRI safety questionnaires 10. If judged unsuitable for the study based on other medical or psychiatric condition according to the PIs best clinical judgment. 11. No depot neuroleptic within 60 days before the day of randomization. 12. Women who are pregnant or breastfeeding, and/or unwilling to take a pregnancy test. Exclusion Criteria for Healthy Control Subjects 1. History of psychiatric disorder or current medical illness |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Unc Psychiatry | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurocognitive Assessment Procedure | Composite score derived from the neurocognitive battery used in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia clinical trial and the Brief Assessment of Cognition in Schizophrenia (BACS). | Baseline, after four weeks of Thiothixine, then follow-up after 8 weeks | No |
Primary | fMRI activation Tasks | During MR imaging subjects performed one visual-auditory target detection task and one auditory oddball task. Subjects completed runs consisting of 160 trials with a total duration of approximately 4 min. During odd numbered runs, subjects performed a visual target detection task. During even numbered runs, subjects performed an auditory target detection task. | Baseline, after four weeks of Thiothixine, then follow-up after 8 weeks | No |
Secondary | Performance accuracy on Visual-auditory target detection task | Per fMRI activation tasks. For the visual task, subjects were asked to pay attention to a screen where two types of stimuli were displayed: 1) Standards were squares of varying size and color that comprised ~95% of trials 2) Targets were circles of varying zize and colors that were presented irriegularly on ~5% of trials. The onsets of successive Targets were separated by a minimum of 15 seconds. | Baseline, after four weeks of Thiothixine, then follow-up after 8 weeks | No |
Secondary | Performance accuracy on Auditory oddball target detection task | Per fMRI activation tasks. Subjects were asked to pay attention to attend to auditory stimuli presented at a rate of one per 500 msecs for each run. Standards were 500 msec duration 440 Hz pure tones that were presented on ~95% of trials. Frequency-deviant Target tones were 500msec duration 800 Hz pure tones presented irregularly on ~5% of trials. The onsets of successive deviant tones were separated by a minimum of 15 seconds. During both tasks subjects were instructed to press a button whenever a Target was presented. No overt or covert response was required of Standards. | baseline, after four weeks of Thiothixine, then follow-up after 8 weeks | No |
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