Study of Paliperidone ER in Adolescents and Young Adults With Autism - Full Text View

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:

Drug Information available for: Paliperidone

U.S. FDA Resources

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:

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
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