Lab School Day Study for CONCERTA of Older Children With ADHD - Study Results

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
Interventions:	Drug: Placebo/ CONCERTA (methylphenidate HCl) Drug: CONCERTA (methylphenidate HCl) / Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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: Overall Study

	Not Randomized	Placebo/Concerta	Concerta/Placebo
STARTED	7	36	35
COMPLETED	0	36	35
NOT COMPLETED	7	0	0
Withdrawal by Subject	1	0	0
Lost to Follow-up	1	0	0
Optimal Dose Not Achieved	2	0	0
Failure to follow study protocol)	1	0	0
Did not attend lab school day 1	1	0	0
medication compliance	1	0	0

Baseline Characteristics

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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

Baseline Measures

	Not Randomized	Placebo/Concerta	Concerta/Placebo	Total
Number of Participants [units: participants]	7	36	35	78
Age [units: years] Mean ± Standard Deviation	9.9 ± 0.69	10.3 ± 1.07	10.0 ± 1.14	10.1 ± 1.08
Gender [units: participants]
Female	3	14	6	23
Male	4	22	29	55
Region of Enrollment [units: participants]
USA	7	36	35	78

Outcome Measures

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1. Primary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score [ Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period ]

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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 ]

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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 ]

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11. Secondary:

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

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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 ]

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13. Secondary:

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

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14. Secondary:

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

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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 ]

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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 ]

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17. Secondary:

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

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18. Secondary:

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

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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 ]

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20. Secondary:

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

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

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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Results Point of Contact:

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

No publications provided by Ortho-McNeil Janssen Scientific Affairs, LLC

Publications automatically indexed to this study:

Wigal SB, Wigal T, Schuck S, Brams M, Williamson D, Armstrong RB, Starr HL. Academic, behavioral, and cognitive effects of OROS® methylphenidate on older children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2011 Apr;21(2):121-31. Epub 2011 Apr 13.

Responsible Party:	Vice President, Medical Affairs, CNS, Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:	NCT00799409 History of Changes
Other Study ID Numbers:	CR015046
Study First Received:	November 26, 2008
Results First Received:	June 14, 2010
Last Updated:	May 18, 2011
Health Authority:	United States: Food and Drug Administration