Study of Paliperidone ER in Adolescents and Young Adults With Autism

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University School of Medicine
• Collaborator: Ortho-McNeil Janssen Scientific Affairs, LLC
• Treatments: Paliperidone Palmitate

Criteria

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