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Sponsored by: |
Indiana University School of Medicine |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00420459 |
The purpose of this study is to determine the effectiveness and tolerability of aripiprazole in the treatment of children and adolescents with FXS. We hypothesize that aripiprazole will be effective in decreasing aggression, SIB, agitation, and interfering repetitive behavior commonly observed in individuals with FXS. We also hypothesize that aripiprazole will be well tolerated.
Condition | Intervention | Phase |
---|---|---|
Fragile X Syndrome Behavioral Problems Associated With Fragile X Syndrome |
Drug: Aripiprazole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
Official Title: | Aripiprazole in Fragile X Syndrome |
Estimated Enrollment: | 12 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Arlene E Kohn, BA | 317-274-1990 | aekohn@iupui.edu |
Contact: Marianna Zaphiriou, BA | 317-278-6253 | mzaphiri@iupui.edu |
United States, Indiana | |
Riley Hospital for Children | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Principal Investigator: Christopher J McDougle, MD |
Principal Investigator: | Christopher J McDougle, MD | Indiana University |
Responsible Party: | Indiana University School of Medicine ( Christopher J. McDougle, M.D. ) |
Study ID Numbers: | FXS01 |
Study First Received: | January 9, 2007 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00420459 |
Health Authority: | United States: Institutional Review Board |
Chromosomal abnormalities X-linked mental retardation and macro-orchidism Chromosome Disorders Fragile X Syndrome Mental Retardation Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn |
Fragile X syndrome Genetic Diseases, X-Linked Neurologic Manifestations Aripiprazole Congenital Abnormalities Neurobehavioral Manifestations |
Disease Tranquilizing Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents |
Pharmacologic Actions Pathologic Processes Syndrome Therapeutic Uses Sex Chromosome Disorders Mental Retardation, X-Linked Central Nervous System Agents |