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Sponsored by: |
Kettering Health Network |
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Information provided by: | Kettering Health Network |
ClinicalTrials.gov Identifier: | NCT00712270 |
This study is being conducted to find a way to predict how individual schizophrenic patients will respond if they are treated with different types of antipsychotic drugs. This could help doctors prescribe the medication that will work best for each individual.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Aripiprazole Drug: Risperidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Double-Blind Trial of Aripiprazole and Risperidone in Schizophrenia: An Evaluation of Neuroimaging, Neuropsychological, and Pharmacogenomic Markers of Differential Treatment Response |
Estimated Enrollment: | 125 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Screening and Baseline Procedures followed by Referral to Community Care. Baseline Procedures may be repeated at a later time if appropriate.
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2: Active Comparator
Screening and Baseline Procedures followed by 16 weeks of treatment with aripiprazole, followed by repeat of baseline procedures and referral to community care.
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Drug: Aripiprazole
Target dose = 15mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible).
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3: Active Comparator
Screening and Baseline Procedures followed by 16 weeks of treatment with Risperidone,followed by repeat of baseline procedures and referral to community care.
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Drug: Risperidone
Target Dose = 2mg by mouth per day for 16 weeks. The dosage will be titrated in accordance with the treating physician's clinical judgment, generally reaching full dosage within one week of initiation. The dosage may be increased as clinically indicated, by the treating physician. Any deviation from these target dosing schedules must be reviewed and approved by the principal investigator, generally prior to the adjustment unless clinical circumstances require more immediate adjustment (in which case the treating physician should consult with the principal investigator as soon as is practically possible).
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The primary objective of the proposed research project is to identify a practical method of predicting differential antipsychotic drug treatment response in patients with schizophrenia. In particular, we will examine differential response to two antipsychotic drugs, aripiprazole and risperidone, that have contrasting pharmacologic activity at D2-type dopamine receptors, i.e., partial agonism vs. antagonism, respectively. A number of candidate predictors will be examined, including neuroimaging parameters (regional neuroanatomical and metabolic variations, fallypride binding to D2-like receptors), neuropsychological testing, clinical features, laboratory measures, and genetic studies.
Secondary objectives include: (1) extension of our previous efforts to characterize abnormalities in cortico-striato-thalamic circuits in unmedicated schizophrenics using PET and MR imaging; and, (2) examination of the role of omega-3 fatty acid activity in schizophrenics as a predictor of dopaminergic activity.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Douglas S Lehrer, MD | 937-395-8251 | doug.lehrer@khnetwork.org |
Contact: Michele Jewell, MA | 937-298-3399 ext 55415 | michele.jewell@khnetwork.org |
United States, Ohio | |
Wallace Kettering Neuroscience Institute | Recruiting |
Kettering, Ohio, United States, 45429 | |
Contact: Douglas S Lehrer, MD 937-395-8251 doug.lehrer@khnetwork.org | |
Contact: Michele Jewell, MA 937-298-3399 ext 55415 michele.jewell@khnetwork.org | |
Principal Investigator: Douglas S. Lehrer, MD |
Principal Investigator: | Douglas S Lehrer, MD | Wallace Kettering Neuroscience Institute |
Responsible Party: | Wallace Kettering Neuroscience Institute ( Douglas S. Lehrer, MD ) |
Study ID Numbers: | 05-009 |
Study First Received: | July 7, 2008 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00712270 |
Health Authority: | United States: Food and Drug Administration |
Schizophrenia Antipsychotic drug treatment response Risperidone Aripiprazole |
Fallypride Positron emission tomography Magnetic Resonance Imaging Dopamine D2 Receptors |
Schizophrenia Dopamine Mental Disorders Risperidone |
Psychotic Disorders Aripiprazole Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |