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Trial record 10 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

Study of Paliperidone ER in Adolescents and Young Adults With Autism

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ClinicalTrials.gov Identifier: NCT00549562
Recruitment Status : Completed
First Posted : October 26, 2007
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Tracking Information
First Submitted Date  ICMJE October 25, 2007
First Posted Date  ICMJE October 26, 2007
Results First Submitted Date  ICMJE April 11, 2017
Results First Posted Date  ICMJE May 16, 2017
Last Update Posted Date May 16, 2017
Study Start Date  ICMJE November 2007
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2007)
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.
Change History Complete list of historical versions of study NCT00549562 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2007)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Paliperidone ER in Adolescents and Young Adults With Autism
Official Title  ICMJE A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autism
Intervention  ICMJE 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
Study Arms  ICMJE Paliperidone ER
8-Week Open-Label
Intervention: Drug: Paliperidone ER
Publications * Stigler KA, Mullett JE, Erickson CA, Posey DJ, McDougle CJ. Paliperidone for irritability in adolescents and young adults with autistic disorder. Psychopharmacology (Berl). 2012 Sep;223(2):237-45. doi: 10.1007/s00213-012-2711-3. Epub 2012 May 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2017)
25
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2007)
30
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00549562
Other Study ID Numbers  ICMJE 0709-24
R076477-AUT-4002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Indiana University ( Indiana University School of Medicine )
Study Sponsor  ICMJE Indiana University School of Medicine
Collaborators  ICMJE Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators  ICMJE
Study Director: David Dunn, MD Indiana Univerity School of Medicine
PRS Account Indiana University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP