Study of Paliperidone ER in Adolescents and Young Adults With Autism

Completed · Phase 3

Conditions studied: Autism

In brief

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.

Key facts

Study ID

NCT00549562

Run by

Indiana University

People needed

25

Starts

2007-11-01

Expected to finish

2010-09-01

Last updated by the study team

2017-05-16

Who can join

Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Riley Child & Adolescent Psychiatry Clinic- Riley Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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