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Study of Paliperidone ER in Adolescents and Young Adults With Autism

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00549562
First received: October 25, 2007
Last updated: June 3, 2014
Last verified: June 2014
History of Changes
  Purpose

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
Autism
 Drug: Paliperidone ER
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
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

  Eligibility
Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00549562

Locations
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
Investigators
Principal Investigator: Kimberly A Stigler, MD Indiana Univerity School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00549562     History of Changes
Other Study ID Numbers: 0709-24, R076477-AUT-4002
Study First Received: October 25, 2007
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Autistic Disorder

Additional relevant MeSH terms:
9-hydroxy-risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
 Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on March 03, 2015