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Study of Paliperidone ER in Adolescents and Young Adults With Autism - NCT00549562-46202(Clinical Trial 188778)



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City:  Indianapolis
State:  
IN
Zip Code: 46202
Conditions: Autism
Purpose: This 8-week, prospective open-label study will investigate the effectiveness and tolerability of paliperidone ER in adolescents and young adults with autism. Hypothesis:Paliperidone Er will be well tolerated and efficacious for reducing aggression, self-injury, and irritability in adolescents and young adults.
Study summary:
Criteria: Inclusion Criteria: - Males and females between ages of 12 and 21 years - Tanner Sage III or IV (post-pubertal) - DSM-IV-TR diagnosis of autism - Outpatient - Ability to swallow pills - Antipsychotic medication-free for at least 2 weeks - Score of 4 or more on the Clinical Global Impressions Severity Scale - Score of 18 or higher on the Aberrant Behavior Checklist Irritability Scale - Mental age of 18 months or greater based on testing - Subjects must be in good physical health Exclusion Criteria: - Asperger's Disorder, PDD NOS, Rett's Disorder, childhood disintegrative disorder, schizophrenia, bipolar disorder, Fragile X Syndrome, Tuberous Sclerosis - A significant medical condition - An active seizure disorder - Females who are pregnant - Evidence of a prior adequate trial of paliperidone ER - History of neuroleptic malignant syndrome - Hypersensitivity to paliperidone ER
Study is available at: Riley Child & Adolescent Psychiatry Clinic- Riley Hospital
Indianapolis, IN 46202
United States

Primary Contact:
Arlene E Kohn
Email: aekohn@iupui.edu
Phone: 317-944-1990

Secondary Contact:
Arlene Kohn, BA
Email: aekohn@iupu.edu
Phone: 317-944-1990
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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