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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: April 11, 2017
Last verified: April 2017
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: Sequential Assignment
Masking: No masking
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 ( Indiana University School of Medicine ):

Primary Outcome Measures:
  • The Clinical Global Impression-Improvement(CGI-I) [ Time Frame: Week 8 ]
    The CGI Global Improvement (CGI-I) is a clinician-rate scale designed to take into account all factors to arrive at an assessment of severity and response to treatment, including parent report, parent-rated measures, teacher-rated measures, and clinician-rated measures. The CGI-I is rated from 1 to 7 (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) at a single time-point.

  • The Aberrant Behavior Checklist [ Time Frame: Week 8 ]
    The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. Each item is rated from 0 (not at all to 3 (severe). The ABC has 5 subscales:Irritability (15 items) ranging from 0 (not at all) to 45 (severe), Hyperactivity (16 items) ranging from 0 (not at all) to 48 (severe), Social Withdrawal (16 items) ranging from 0 (not at all) to 48 (severe), Stereotypy (7 items) ranging from 0 (not at all) to 21 (severe) and Inappropriate Speech (4 items) ranging from 0 (not at all) to 12 (severe).

Secondary Outcome Measures:
  • The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders [ Time Frame: Week 8 ]
    The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders (CY-BOCS-PDD) is semi-structured clinician rating scale designed to rate the current severity of repetitive behavior in children and adolescents with PDD. The scale consists of 5 items: Time Spent, Interference, Distress, Resistance and Control. Each item is scored from 0 (None) to 4 (Extreme). The scale yields a Total Score from 0 (least symptomatic) to 20 (most symptomatic). Higher scores indicate greater severity of repetitive behavior.

  • The Social Responsiveness Scale [ Time Frame: Week 8 ]
    The Social Responsiveness Scale (SRS) is a 65-item parent completed scale that assesses social awareness, social cognition, social communication, social motivation and autistic mannerisms. Each item is scored from 1 (not true) to 3 (almost always true). Interpretation in this study is based on a total score that is proportional to the level of impairment in reciprocal social behavior. Scores within 0-53 are within normal limits. Scores within 54-86 indicate mild to moderate impairment. Scores above 87 indicate severe impairment.

  • The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain [ Time Frame: Week 8 ]
    The VABS Maladaptive Behavior Domain measures undesirable behaviors that may interfere with an individual's adaptive functioning. The Maladaptive Domain consists two parts. Part I contains 27 minor maladaptive items and Part II contains 9 serious maladaptive behaviors. Each item is scored from 0 (never or seldom engages in the activity) to 2(usually or habitually engages in the activity). Part 1 yields a score of 0 to 54. Part II yields a score of 0 to 18. Both parts are combined to make a Total Score of 0 to 72. High scores of maladaptive behaviors reflect more negative behavior.

Enrollment: 25
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
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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
Study Director: David Dunn, 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
Results First Received: April 11, 2017
Last Updated: April 11, 2017

Keywords provided by Indiana University ( Indiana University School of Medicine ):
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 May 25, 2017