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Sponsors and Collaborators: |
Medical College of Georgia Ortho-McNeil Janssen Scientific Affairs, LLC |
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Information provided by: | Medical College of Georgia |
ClinicalTrials.gov Identifier: | NCT00352196 |
This study will be an open-label, 12-week trial of risperidone in subjects with Asperger's Disorder, according to DSM-IV Criteria. The study has two arms, one involving pre- and post-treatment MRS studies, and one without MRS. The MRS arm will study 18-20 subjects ages 6 and above, with a target of 14 completing patients. For both arms, we plan to a enroll at total of 30 patients to achieve completion for 24 patients. The non-MRS arm of the study will include subjects 6-18 years of age, the bulk of which have completed the study as of the writing of this updated revision. Our hypotheses are that treatment of Asperger's patients with a low dose of risperidone will:
Specific Aims
The primary objectives of this trial are to:
This information could potentially be used to provide pilot data for a double blind trial
Condition | Intervention | Phase |
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Asperger's Disorder |
Drug: risperidone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Biological Basis of Therapy for Negative Symptom Spectrum Disorders: Risperdal Effect on Frontal Metabolism in Asperger's Disorder |
Estimated Enrollment: | 50 |
Study Start Date: | November 2001 |
Estimated Study Completion Date: | September 2008 |
Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with an anticipated life expectancy of six months or less.
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United States, Georgia | |
Medical College of Georgia, Dept. of Psychiatry | |
Augusta, Georgia, United States, 30912-3800 |
Principal Investigator: | Jeffrey L Rausch, MD | Medical College of Georgia |
Study Director: | Donna L Londino, MD | Medical College of Georgia |
Study ID Numbers: | RIS-EMR-4026, MCG HAC File #01-09-063 |
Study First Received: | July 12, 2006 |
Last Updated: | December 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00352196 |
Health Authority: | United States: Institutional Review Board |
Asperger's Disorder Risperidone Magnetic Resonance Spectroscopy Social Skills |
Developmental Disabilities Child Development Disorders, Pervasive Dopamine Mental Disorders |
Mental Disorders Diagnosed in Childhood Asperger Syndrome Risperidone Serotonin |
Neurotransmitter Agents Disease 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 Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |