Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Study of Paliperidone ER in Adolescents and Young Adults With Autism

This study has been completed.
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine ) Identifier:
First received: October 25, 2007
Last updated: May 14, 2015
Last verified: May 2015
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.

Condition Intervention Phase
Drug: Paliperidone ER
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism

Resource links provided by NLM:

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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. [ Time Frame: At every visit ]

Secondary Outcome Measures:
  • 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. [ Time Frame: To be done at baseline and endpoint ]

Enrollment: 30
Study Start Date: November 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Paliperidone ER
8-Week Open-Label
Drug: Paliperidone ER
Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.
Other Name: Invega


Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00549562

United States, Indiana
Riley Child & Adolescent Psychiatry Clinic- Riley Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Ortho-McNeil Janssen Scientific Affairs, LLC
Principal Investigator: Kimberly A Stigler, MD Indiana Univerity School of Medicine
  More Information

Responsible Party: Indiana University School of Medicine Identifier: NCT00549562     History of Changes
Other Study ID Numbers: 0709-24
Study First Received: October 25, 2007
Last Updated: May 14, 2015

Keywords provided by Indiana University:
Autistic Disorder

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Paliperidone Palmitate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents processed this record on April 28, 2017