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Study of the Effects of Osmotic-Release Oral System (OROS) Methylphenidate (Concerta) on Attention and Memory (CHOP)

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00530257
First received: September 13, 2007
Last updated: November 15, 2011
Last verified: November 2011
Results First Received: March 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Interventions: Drug: Placebo
Drug: OROS-methylphenidate

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

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
OROS Methylphenidate Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed on the measures described below.

Baseline Measures
   OROS Methylphenidate 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Participants]
 
<=18 years   30 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.5  (1.9) 
Gender 
[Units: Participants]
 
Female   6 
Male   24 
Region of Enrollment 
[Units: Participants]
 
United States   30 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Test of Everyday Attention for Children: Walk, Don't Walk   [ Time Frame: 2 weeks ]

2.  Primary:   Gordon Diagnostic System Continuous Performance Test   [ Time Frame: 2 weeks ]

3.  Primary:   Wechsler Intelligence Scale for Children-IV, Digit Span Subtest   [ Time Frame: 2 weeks ]

4.  Primary:   Test of Everyday Attention for Children-Sky Search Dual Task   [ Time Frame: 2 weeks ]

5.  Primary:   Test of Everyday Attention for Children: Score Dual Task (DT)   [ Time Frame: 2 weeks ]

6.  Primary:   Test of Everyday Attention for Children: Creature Counting   [ Time Frame: 2 weeks ]

7.  Primary:   Test of Everyday Attention for Children: Map Mission   [ Time Frame: 2 weeks ]
  Hide Outcome Measure 7

Measure Type Primary
Measure Title Test of Everyday Attention for Children: Map Mission
Measure Description The TEA-Ch is a battery of nine subtests designed to assess multiple attentional capacities in children 6-16y.o. The Map Mission subtest is a measure of selective attention and indicates the number of targets found in one minute. Scores on this subtest can range from 0 to over 70 with higher scores representing improved performance.
Time Frame 2 weeks  

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.
Crossover design, all 30 of the 31 subjects completed both the placebo and medication phase of the study and were the group analyzed

Reporting Groups
  Description
Medication Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
Placebo This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases

Measured Values
   Medication   Placebo 
Participants Analyzed 
[Units: Participants]
 30   30 
Test of Everyday Attention for Children: Map Mission 
[Units: Units on a scale]
Median (Full Range)
 27.5 
 (15 to 57) 
 27 
 (10 to 52) 


Statistical Analysis 1 for Test of Everyday Attention for Children: Map Mission
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Wilcoxon (Mann-Whitney)
P Value [4] <0.01
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Same as described for TEA-Ch: Walk, Don't Walk
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Same as described for TEA-Ch: Walk, Don't Walk



8.  Primary:   Test of Everyday Attention for Children: Sky Search   [ Time Frame: 2 weeks ]

9.  Primary:   Test of Everyday Attention for Children: Opposite Worlds   [ Time Frame: 2 weeks ]

10.  Secondary:   Behavior Rating Inventory of Executive Function   [ Time Frame: 2 Weeks ]

11.  Secondary:   ADHD Rating Scale-IV, Parent and Teacher Version   [ Time Frame: 2 Weeks ]

12.  Other Pre-specified:   Stimulant Side Effect Rating Scale   [ Time Frame: 2 weeks ]


  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
No text entered.


  More Information