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CONCERTA Lab School Study

This study has been completed.
Sponsor:
Information provided by:
Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT00799487
First received: November 26, 2008
Last updated: May 18, 2011
Last verified: March 2011
Results First Received: June 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder
Intervention: Drug: CONCERTA (methylphenidate HCl) or placebo

  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
Not Randomized Children who started dose adjustment period, but were not randomized
Placebo/Concerta Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
Concerta/Placebo Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2

Participant Flow for 2 periods

Period 1:   Dose Adjustment Period
    Not Randomized     Placebo/Concerta     Concerta/Placebo  
STARTED     21     34     34  
COMPLETED     0     34     34  
NOT COMPLETED     21     0     0  
Lost to Follow-up                 1                 0                 0  
Adverse Event                 2                 0                 0  
Optimal Dose Not Achieved                 8                 0                 0  
Investigator Discretion                 2                 0                 0  
Withdrawal by Subject                 3                 0                 0  
Parent to home school child (exclusion)                 1                 0                 0  
Child too young (exclusion)                 1                 0                 0  
Missed laboratory day 1                 1                 0                 0  
ADHD RS-IV rating scale >85th percentile                 2                 0                 0  

Period 2:   Double-Blind Assessment Period
    Not Randomized     Placebo/Concerta     Concerta/Placebo  
STARTED     0     34     34  
COMPLETED     0     33     32  
NOT COMPLETED     0     1     2  
Lost to Follow-up                 0                 0                 1  
Subject was out of the state                 0                 0                 1  
Overslept and missed lab day 2                 0                 1                 0  



  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
Not Randomized Children who started dose adjustment period, but were not randomized
Placebo/Concerta Children randomized to receive Placebo at lab school day 1 and Concerta lab school day 2
Concerta/Placebo Children randomized to receive Concerta at lab school day 1 and Placebo at lab school day 2
Total Total of all reporting groups

Baseline Measures
    Not Randomized     Placebo/Concerta     Concerta/Placebo     Total  
Number of Participants  
[units: participants]
  21     34     34     89  
Age  
[units: years]
Mean ± Standard Deviation
  10.0  ± 1.00     10.1  ± 1.07     10.4  ± 0.99     10.2  ± 1.03  
Gender  
[units: participants]
       
Female     6     14     9     29  
Male     15     20     25     60  
Region of Enrollment  
[units: participants]
       
USA     21     34     34     89  



  Outcome Measures
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1.  Primary:   Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)   [ Time Frame: Hour 4 of the Double-Blind Assessment Period Lab School Day ]

2.  Primary:   Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)   [ Time Frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period ]

3.  Secondary:   Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)   [ Time Frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period ]

4.  Secondary:   Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)   [ Time Frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period ]

5.  Secondary:   Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)   [ Time Frame: Hour 4 of the Lab School Day During the Double-Blind Assessment Period ]

6.  Secondary:   Hour 5.5 Test of Variables of Attention (TOVA) ADHD Score   [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]

7.  Secondary:   Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time (Msec)   [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]

8.  Secondary:   Hour 5.5 Test of Variables of Attention(TOVA) Reaction Time Variability (Standard Deviation in Milliseconds (Msecs))   [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]

9.  Secondary:   Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards   [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]

10.  Secondary:   Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards   [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]

11.  Secondary:   Hour 5.5 Test of Variables of Attention (TOVA) Commissions   [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]

12.  Secondary:   Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards   [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]

13.  Secondary:   Hour 8.75 Gray Silent Reading Test (GSRT)   [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ]

14.  Secondary:   Hour 7.5 Test of Handwriting Skills (Revised) (THS-R)   [ Time Frame: Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period ]

15.  Secondary:   Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)   [ Time Frame: Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period ]

16.  Secondary:   Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards   [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]

17.  Secondary:   Hour 5.5 Test of Variables of Attention (TOVA) Omissions   [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]

18.  Secondary:   Hour 3.0 Grammar Task   [ Time Frame: Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period ]

19.  Secondary:   Hour 8.75 Packet Activity - Short Story With Questions for Comprehension   [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ]

20.  Secondary:   Hour 8.75 Packet Activity - Identiy Root Word   [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ]

21.  Secondary:   Hour 8.75 Packet Activity - Alphabetize List of Words   [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ]

22.  Secondary:   Hour 8.75 Packet Activity - Identify Multiple Meanings for Words   [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ]

23.  Secondary:   Hour 8.75 Packet Activity - Complete Sentences Using Words Provided   [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ]

24.  Secondary:   Hour 8.75 Packet Activity - Word Search   [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ]

25.  Secondary:   Hour 8.75 Packet Activity - Decode the Mystery Sentence   [ Time Frame: Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period ]


  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: VP Medical Affairs, CNS
Organization: Ortho-McNeil Janssen Scientific Affairs, LLC
phone: 609-730-2136


No publications provided


Responsible Party: Vice President, Medical Affairs, CNS, Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00799487     History of Changes
Other Study ID Numbers: CR015118
Study First Received: November 26, 2008
Results First Received: June 25, 2010
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration