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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: April 11, 2017
Last verified: April 2017
  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: 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

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Study Director: David Dunn, MD Indiana Univerity School of Medicine
  More Information

Publications:
Responsible Party: 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
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

ClinicalTrials.gov processed this record on July 25, 2017