Study of Paliperidone ER in Adolescents and Young Adults With Autism

Indiana University School of Medicine

Status and phase: Completed; Phase 3

Conditions: Autism

Treatments: Drug: Paliperidone ER

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00549562

0709-24

R076477-AUT-4002

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Paliperidone ER

Other group

Description:

8-Week Open-Label

Treatment:

Drug: Paliperidone ER