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Study of Paliperidone ER in Adolescents and Young Adults With Autism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549562
First Posted: October 26, 2007
Last Update Posted: May 16, 2017
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.
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
Results First Submitted: April 11, 2017  
Study Type: Interventional
Study Design: Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Autism
Intervention: Drug: Paliperidone ER

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Paliperidone ER

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.


Participant Flow:   Overall Study
    Paliperidone ER
STARTED   25 
COMPLETED   23 
NOT COMPLETED   2 
Adverse Event                1 
Lack of Efficacy                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Paliperidone ER

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.


Baseline Measures
   Paliperidone ER 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      20  80.0% 
Between 18 and 65 years      5  20.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Full Range)
 15.36 
 (12 to 21) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  16.0% 
Male      21  84.0% 
Region of Enrollment 
[Units: Participants]
 
United States   25 
Clinical Global Impressions-Improvement (CGI-I) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.0  (0.0) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
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] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 16  (3) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 122.6  (18.4) 
[1] 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] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
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] 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.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Clinical Global Impression-Improvement(CGI-I)   [ Time Frame: Week 8 ]

2.  Primary:   The Aberrant Behavior Checklist   [ Time Frame: Week 8 ]

3.  Secondary:   The Children's Yale-Brown Obsessive Compulsive Scale Modified for Pervasive Developmental Disorders   [ Time Frame: Week 8 ]

4.  Secondary:   The Social Responsiveness Scale   [ Time Frame: Week 8 ]

5.  Secondary:   The Vineland Adaptive Behavior Scales (VABS) - Maladaptive Behavior Domain   [ Time Frame: Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: ddunn@iupui.edu


Publications:

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