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| Sponsor: | Medical College of Georgia |
|---|---|
| Collaborator: |
Ortho-McNeil Janssen Scientific Affairs, LLC |
| Information provided by: | Medical College of Georgia |
| ClinicalTrials.gov Identifier: | NCT00352196 |
Purpose
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 |
|---|---|---|
|
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 |
Show Detailed Description
Eligibility| 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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Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Asperger's Disorder Risperidone Magnetic Resonance Spectroscopy Social Skills |
|
Neurotransmitter Agents Tranquilizing Agents Disease Molecular Mechanisms of Pharmacological Action Asperger Syndrome Physiological Effects of Drugs Psychotropic Drugs Risperidone Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents |
Pharmacologic Actions Child Development Disorders, Pervasive Serotonin Antagonists Pathologic Processes Serotonin Agents Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Dopamine Agents Central Nervous System Agents |