ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Paliperidone ER in Adolescents and Young Adults With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00549562
Recruitment Status : Completed
First Posted : October 26, 2007
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Study Type Interventional
Study Design Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Autism
Intervention Drug: Paliperidone ER
Enrollment 25

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Paliperidone ER
Hide Arm/Group Description

8-Week Open-Label

Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day.

Period Title: Overall Study
Started 25
Completed 23
Not Completed 2
Reason Not Completed
Adverse Event             1
Lack of Efficacy             1
Arm/Group Title Paliperidone ER
Hide Arm/Group Description

8-Week Open-Label

Paliperidone ER: starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day.

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
20
  80.0%
Between 18 and 65 years
5
  20.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
15.36
(12 to 21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
4
  16.0%
Male
21
  84.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
Clinical Global Impressions-Improvement (CGI-I)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants
4.0  (0.0)
[1]
Measure 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.
The Aberrant Behavior Checklist   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants
ABC-Irritability 30.3  (6.5)
ABC-Hyperactivity 34.7  (8.9)
ABC-Social Withdrawal 17.2  (12.5)
ABC-Stereotypy 12.5  (6.7)
ABC-Inappropriate Speech 7.5  (4.4)
[1]
Measure Description: The Aberrant Behavior Checklist (ABC) is a 58-item measure of maladaptive behaviors and is used as a measure of drug effects. 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). Items are rated from 0 (not at all) to 3 (severe).
Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants
16  (3)
[1]
Measure 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.
The Social Responsiveness Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants
122.6  (18.4)
[1]
Measure 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.
The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 25 participants
VABS Maladaptive Behavior Subscale Part I 28.9  (6.3)
VABS Maladaptive Behavior Subscale Part II 8.8  (6.4)
VABS Maladaptive Behavior Subscale Total 37.4  (8.2)
[1]
Measure 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.
1.Primary Outcome
Title The Clinical Global Impression-Improvement(CGI-I)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:

8-Week Open-Label

Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day.

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (1.3)
2.Primary Outcome
Title The Aberrant Behavior Checklist
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:

8-Week Open-Label

Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day.

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
ABC-Irritability 12.6  (9.1)
ABC-Hyperactivity 17.4  (11.5)
ABC-Social Withdrawal 7.6  (8.8)
ABC-Stereotypy 6.4  (5.1)
ABC-Inappropriate Speech 3.4  (3.8)
3.Secondary Outcome
Title The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:

8-Week Open-Label

Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day.

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.9  (4.0)
4.Secondary Outcome
Title The Social Responsiveness Scale
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:

8-Week Open-Label

Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day.

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
100.9  (20.4)
5.Secondary Outcome
Title The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paliperidone ER
Hide Arm/Group Description:

8-Week Open-Label

Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day.

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
VABS Maladaptive Behavior Subscale-Part I 19.0  (6.9)
VABS Maladaptive Behavior Subjscale Part II 6.4  (3.4)
VABS Maladaptive Behavior Subscale Total 25.1  (8.8)
Time Frame Eight Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone ER
Hide Arm/Group Description

8-Week Open-Label

Paliperidone ER: Starting dose is 3 mg per day, with the option to increase the dose by 3 mg/day on a weekly basis for 4 weeks to a maximum dose of 12 mg per day.

All-Cause Mortality
Paliperidone ER
Affected / at Risk (%)
Total   0/25 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone ER
Affected / at Risk (%) # Events
Total   0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Paliperidone ER
Affected / at Risk (%) # Events
Total   21/25 (84.00%)    
Cardiac disorders   
Palpitations   1/25 (4.00%)  1
Gastrointestinal disorders   
Excessive Appetite   9/25 (36.00%)  9
Constipation   3/25 (12.00%)  3
Diarrhea   2/25 (8.00%)  2
Dyspepsia   1/25 (4.00%)  1
General disorders   
Tiredness   7/25 (28.00%)  7
Rhinitis/cough   8/25 (32.00%)  8
Excessive saliva   2/25 (8.00%)  2
Dry Mouth   1/25 (4.00%)  1
Metabolism and nutrition disorders   
Weight Gain   9/25 (36.00%)  9
Nervous system disorders   
Tremor   1/25 (4.00%)  1
Headache   1/25 (4.00%)  1
Tic   1/25 (4.00%)  1
Akathisia   1/25 (4.00%)  1
Psychiatric disorders   
Insomnia   3/25 (12.00%)  3
Renal and urinary disorders   
Enuresis   1/25 (4.00%)  1
Skin and subcutaneous tissue disorders   
Rash   2/25 (8.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David D. Dunn MD
Organization: Indiana University School of Medicine
Phone: 317-944-8164
Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00549562     History of Changes
Other Study ID Numbers: 0709-24
R076477-AUT-4002
First Submitted: October 25, 2007
First Posted: October 26, 2007
Results First Submitted: April 11, 2017
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017