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

Arm | Intervention/treatment |
---|---|
Paliperidone ER
8-Week Open-Label
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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 |
- 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).
- 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.

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Ages Eligible for Study: | 12 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549562
United States, Indiana | |
Riley Child & Adolescent Psychiatry Clinic- Riley Hospital | |
Indianapolis, Indiana, United States, 46202 |
Study Director: | David Dunn, MD | Indiana Univerity School of Medicine |
Responsible Party: | Indiana University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00549562 |
Other Study ID Numbers: |
0709-24 R076477-AUT-4002 |
First Posted: | October 26, 2007 Key Record Dates |
Results First Posted: | May 16, 2017 |
Last Update Posted: | May 16, 2017 |
Last Verified: | April 2017 |
Autistic Disorder |
Autistic Disorder Autism Spectrum 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 |