Study of Paliperidone ER in Adolescents and Young Adults With Autism
- Registration Number
- NCT00549562
- Lead Sponsor
- Indiana University School of Medicine
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Paliperidone ER Paliperidone ER 8-Week Open-Label
- Primary Outcome Measures
Name Time Method The Aberrant Behavior Checklist 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 Clinical Global Impression-Improvement(CGI-I) 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.
- Secondary Outcome Measures
Name Time Method The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders 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 Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain 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.
The Social Responsiveness Scale 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.
Trial Locations
- Locations (1)
Riley Child & Adolescent Psychiatry Clinic- Riley Hospital
🇺🇸Indianapolis, Indiana, United States