Study of Paliperidone ER in Adolescents and Young Adults With Autism

NCT00549562 | Completed Phase 3 Results DMC

• 2 other identifiers: 0709-24R076477-AUT-4002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism

Keywords

Autistic Disorder

Outcome Measures

Primary Outcomes (2)

• The Clinical Global Impression-Improvement(CGI-I)

  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.

  Week 8

• The Aberrant Behavior Checklist

  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).

  Week 8

Secondary Outcomes (3)

• The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders

  Week 8

• The Social Responsiveness Scale

  Week 8

• The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain

  Week 8

Study Arms (1)

Paliperidone ER

OTHER

8-Week Open-Label

Drug: Paliperidone ER

Interventions

Paliperidone ER DRUG

Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.

Also known as: Invega

Paliperidone ER

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Riley Child & Adolescent Psychiatry Clinic- Riley Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 22549762 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: David D. Dunn MD
• Organization: Indiana University School of Medicine

ddunn@iupui.edu

317-944-8164

Study Officials

• David Dunn, MD

  Indiana Univerity School of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 26, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 16, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-04

Locations

US (1)