Study of Paliperidone ER in Adolescents and Young Adults With Autism

Autism Clinical Trial

Official title:

A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549562
• Other study ID #: 0709-24
• Secondary ID: R076477-AUT-4002
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2007
• Last updated: May 14, 2015
• Start date: November 2007
• Est. completion date: September 2010

Study information

• Verified date: May 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 21 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Drug:
• Paliperidone ER
Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.

Locations

Country	Name	City	State
United States	Riley Child & Adolescent Psychiatry Clinic- Riley Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Ortho-McNeil Janssen Scientific Affairs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Irritability subscale of the Aberrant Behavior Checklist (ABC) will be used as the caregiver-rated primary outcome measure. The Clinical Global Impression-Improvement(CGI-I) will be included as a primary outcome measure.		At every visit	No
Secondary	Secondary outcome measures include the all the other subscales of the ABC, the Vineland Adaptive Behavior Scales,the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Social Responsiveness Scale.		To be done at baseline and endpoint	No