Study of Paliperidone ER in Adolescents and Young Adults With Autism

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Autism	Drug: Paliperidone ER	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Intervention Model:	Sequential Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism
Study Start Date :	November 2007
Actual Primary Completion Date :	September 2010
Actual Study Completion Date :	September 2010

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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.
2. 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 :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

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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

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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

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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.

Responsible Party:	Indiana University School of Medicine
ClinicalTrials.gov Identifier:	NCT00549562 History of Changes
Other Study ID Numbers:	0709-24; R076477-AUT-4002
First Posted:	October 26, 2007
Results First Posted:	May 16, 2017
Last Update Posted:	May 16, 2017
Last Verified:	April 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