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Indianapolis, Indiana 46202


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.


Inclusion Criteria: - Males and females between ages of 12 and 21 years - Tanner Sage III or IV (post-pubertal) - Diagnostic and Statistical Manual Fourth Edition Text-Revised (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, Pervasive Developmental Disorder Not Otherwise Specified (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



Primary Contact:

Principal Investigator
Kimberly A Stigler, MD
Indiana Univerity School of Medicine

Backup Contact:


Location Contact:

Indianapolis, Indiana 46202
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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