Back to resultsStudy of Paliperidone ER in Adolescents and Young Adults With Autism
Primary Purpose
Autism
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Paliperidone ER
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autistic Disorder
Eligibility 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
Sites / Locations
- Riley Child & Adolescent Psychiatry Clinic- Riley Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Paliperidone ER
Arm Description
8-Week Open-Label
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders
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
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
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.
Full Information
NCT ID
NCT00549562
First Posted
October 25, 2007
Last Updated
April 11, 2017
Sponsor
Indiana University School of Medicine
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00549562
Brief Title
Study of Paliperidone ER in Adolescents and Young Adults With Autism
Official Title
A Prospective, Open-Label Study of Paliperidone ER in Adolescents and Young Adults With Autism
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine
Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Autistic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paliperidone ER
Arm Type
Other
Arm Description
8-Week Open-Label
Intervention Type
Drug
Intervention Name(s)
Paliperidone ER
Other Intervention Name(s)
Invega
Intervention Description
Starting dose is 3 mg per day. Can be titrated up to a maximum dose of 9 mg per day.
Primary Outcome Measure Information:
Title
The Clinical Global Impression-Improvement(CGI-I)
Description
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.
Time Frame
Week 8
Title
The Aberrant Behavior Checklist
Description
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).
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders
Description
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.
Time Frame
Week 8
Title
The Social Responsiveness Scale
Description
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.
Time Frame
Week 8
Title
The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain
Description
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.
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Dunn, MD
Organizational Affiliation
Indiana Univerity School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Riley Child & Adolescent Psychiatry Clinic- Riley Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22549762
Citation
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.
Results Reference
background
Learn more about this trial
Study of Paliperidone ER in Adolescents and Young Adults With Autism
We'll reach out to this number within 24 hrs