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    Clinical Trial Results:
    A Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral, and Cognitive Effects of CONCERTA on Older Children with ADHD

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2015-001081-26
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 Jun 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Jul 2016
    First version publication date
    31 Jul 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CONCERTAATT4069
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00799409
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ortho-McNeil Janssen Scientific Affairs LLC
    Sponsor organisation address
    1125 Trenton-Harbourton Road, Titusville, New Jersey, United States, 08560- 0200
    Public contact
    Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jun 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with attention deficit hyperactivity disorder (ADHD), when compared to placebo.
    Protection of trial subjects
    Safety were evaluated throughout the study by monitoring of adverse events (AEs), laboratory tests (complete blood count [CBC], complete chemistry panel, and liver function tests [LFTs]), vital signs body weight measurements, electrocardiogram and the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) including items specifically examining suicidal thinking.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 78
    Worldwide total number of subjects
    78
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    67
    Adolescents (12-17 years)
    11
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Total 78 subjects were enrolled in the study and out of 78 only only 71 subjects completed the study.

    Period 1
    Period 1 title
    Open-Label Dose Adjustment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Concerta
    Arm description
    		 Subjects initiated with Concerta as 18 milligram/day (mg/day) once daily. Concerta dose was continuously increased until an optimal individualized dose was achieved, up to a maximum dose of 54 mg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Concerta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Concerta (18 mg, 36 mg, or 54 mg) tablet once daily orally was administered.

    Number of subjects in period 1
    		Concerta
    Started
    78
    Completed
    71
    Not completed
    7
         Consent withdrawn by subject
    1
         Other
    5
         Lost to follow-up
    1
    Period 2
    Period 2 title
    Double-Blind Assessment Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo/Concerta
    Arm description
    		 Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18 mg, 36 mg, or 54 mg tablet) once daily at lab school Day 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received placebo matching with Concerta orally once daily

    Investigational medicinal product name
    Concerta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Concerta (18mg, 36mg, or 54 mg) orally tablet was given once daily

    Arm title
    		 Concerta/Placebo
    Arm description
    		 Children randomized to receive an individualized, optimal dose of Concerta (18 mg, 36 mg, or 54 mg tablet) once daily at lab school Day 1 and Placebo at lab school Day 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Concerta
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Concerta (18mg, 36mg, or 54 mg) orally tablet was given once daily.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received placebo matching with Concerta orally once daily

    Number of subjects in period 2
    		Placebo/Concerta Concerta/Placebo
    Started
    36
    35
    Completed
    36
    35

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-Label Dose Adjustment Period
    Reporting group description
    		 Subjects initiated with Concerta as 18 milligram/day (mg/day) once daily. Concerta dose was continuously increased until an optimal individualized dose was achieved, up to a maximum dose of 54 mg/day.

    Reporting group values
    		 Open-Label Dose Adjustment Period Total
    Number of subjects
    		 78 78
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 67 67
        Adolescents (12-17 years)
    		 11 11
        Adults (18-64 years)
    		 0 0
        From 65 to 84 years
    		 0 0
        85 years and over
    		 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.9 ± 0.69 -
    Title for Gender
    Units: subjects
        Female
    		 23 23
        Male
    		 55 55

    End points

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    End points reporting groups
    Reporting group title
    Concerta
    Reporting group description
    		 Subjects initiated with Concerta as 18 milligram/day (mg/day) once daily. Concerta dose was continuously increased until an optimal individualized dose was achieved, up to a maximum dose of 54 mg/day.
    Reporting group title
    Placebo/Concerta
    Reporting group description
    		 Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18 mg, 36 mg, or 54 mg tablet) once daily at lab school Day 2.

    Reporting group title
    Concerta/Placebo
    Reporting group description
    		 Children randomized to receive an individualized, optimal dose of Concerta (18 mg, 36 mg, or 54 mg tablet) once daily at lab school Day 1 and Placebo at lab school Day 2.

    Subject analysis set title
    Intent-to-treat (ITT) population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-Treat for Placebo and Concerta columns in the primary and secondary results are comprised of the 36 children randomized to Placebo/Concerta (lab day 1/lab day 2) plus the 35 children randomized to Concerta/Placebo.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children randomized to receive Placebo at lab school day 1 or lab school day 2

    Subject analysis set title
    Concerta
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Children randomized to receive Concerta at lab school day 1 or lab school day 2

    Primary: Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)

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    End point title
    		 Hour 4 Permanent Product Math Test Attempted Score (PERMP-Attempted)
    End point description
    PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of attempted problems. A higher number of problems attempted was indicative of greater attention to detail (higher score is preferable)
    End point type
    Primary
    End point timeframe
    Hour 4 of the of the Lab School Day during Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [1]
    71 [2]
    Units: Problems attempted
        arithmetic mean (standard deviation)
    74.8 ± 42.05
    103.5 ± 38.51
    Notes
    [1] - ITT Population
    [2] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Concerta
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -28.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35
         upper limit
    		 -22.3
    Notes
    [3] - Number of subjects included in the analysis were “71” instead of "142", as same subjects received both treatments (Placebo and Concerta), one in each treatment period.

    Primary: Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)

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    End point title
    		 Hour 4 Permanent Product Math Test Correct Score (PERMP-Correct)
    End point description
    PERMP (range: 0, 400) is a measure of academic productivity in children up to 14 years of age. These seatwork math tasks provide an objective measure of attention and accuracy in calculations. The level of difficulty is established on a screening math pretest performed at Visit 2. The subsequent laboratory school day assessments employed a series of 10-minute math tests (5 pages of 80 math problem each for a total of 400 problems available). Children were graded on the number of correct problems. A higher number of problems correct, of those attempted, was indicative of greater accuracy.
    End point type
    Primary
    End point timeframe
    Hour 4 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [4]
    71 [5]
    Units: Problems correct
        arithmetic mean (standard deviation)
    69 ± 41.02
    97.4 ± 38.99
    Notes
    [4] - ITT Population
    [5] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Concerta
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -28.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.4
         upper limit
    		 -22.2
    Notes
    [6] - Number of subjects included in the analysis were “71” instead of "142", as same subjects received both treatments (Placebo and Concerta), one in each treatment period.

    Secondary: Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)

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    End point title
    		 Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Deportment (SKAMP-Deportment)
    End point description
    The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Deportment (SKAMP-D) (range: 0, 36) is a sum of ratings on 6 deportment items (interacting with other children, interacting with adults, remaining quiet, staying seated, complying with the teacher’s directions, and following the classroom rules). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.
    End point type
    Secondary
    End point timeframe
    Hour 4 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [7]
    71 [8]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    9 ± 6.68
    3.1 ± 4.1
    Notes
    [7] - ITT Population
    [8] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)

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    End point title
    		 Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Attention (SKAMP-Attention)
    End point description
    The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. The SKAMP-Attention (SKAMP-A) (range: 0, 42) is a sum of the ratings on 7 attention items (getting started, sticking with tasks, attending to an activity, making activity transitions, completing assigned tasks, performing work accurately, and being neat and careful while writing or drawing). Each item was rated on a 7-point impairment scale (0=normal, 6=maximum impairment), with higher scores indicating more severe symptoms.
    End point type
    Secondary
    End point timeframe
    Hour 4 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [9]
    71 [10]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    11.8 ± 6.48
    6.7 ± 5.03
    Notes
    [9] - ITT Population
    [10] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)

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    End point title
    		 Hour 4 Swanson, Kotkin, Alger, M-Flynn and Pelham Scale for Composite (SKAMP-Composite)
    End point description
    The SKAMP scale measures the manifestations of ADHD using an independent observer (teacher) rating of the child's impairment in classroom behavior. A composite score (range: 0, 78) for the SKAMP variable (13 items total) was obtained by summing the SKAMP-D and SKAMP-A subscale scores. A lower score was preferable, as a higher score represented greater behavioral impairment.
    End point type
    Secondary
    End point timeframe
    Hour 4 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [11]
    71 [12]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    20.8 ± 11.23
    9.9 ± 7.44
    Notes
    [11] - ITT Population
    [12] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score

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    End point title
    		 Hour 5.5 Test of Variables of Attention (TOVA) ADHD Composite Cutoff Score
    End point description
    The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicate better performance, lower scores indicate worse performance. Clinical interpretation: an ADHD scores of -1.80 or lower (<= -1.80) are considered not within normal limits scores above -1.80 (> -1.80) are considered inconclusive (meaning, neither like-ADHD nor like-normal).
    End point type
    Secondary
    End point timeframe
    Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [13]
    71 [14]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -4.39 ± 3.31
    -1.34 ± 3.43
    Notes
    [13] - ITT Population
    [14] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score

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    End point title
    		 Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Standard Score
    End point description
    The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.
    End point type
    Secondary
    End point timeframe
    Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [15]
    71 [16]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    73.8 ± 23.74
    89.72 ± 21.32
    Notes
    [15] - ITT Population
    [16] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score

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    End point title
    		 Hour 5.5 Test of Variables of Attention (TOVA) Reaction Time Variability Standard Score
    End point description
    The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.
    End point type
    Secondary
    End point timeframe
    Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [17]
    71 [18]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    62.87 ± 33.789
    85.14 ± 34.906
    Notes
    [17] - ITT Population
    [18] - ITT Population
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v Concerta
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -22.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.43
         upper limit
    		 -17.47

    Secondary: Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards

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    End point title
    		 Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Backwards
    End point description
    End point type
    Secondary
    End point timeframe
    Time Frame: Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [19]
    71 [20]
    Units: Correct Sequences
        arithmetic mean (standard deviation)
    11.2 ± 4.25
    12.2 ± 3.57
    Notes
    [19] - ITT Population
    [20] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards

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    End point title
    		 Hour 5.5 Wide Range Assessment of Memory and Learning (WRAML-2) Finger Windows Forwards
    End point description
    WRAML-2 (range: 0, 28) is designed to evaluate a child's ability to learn and to memorize information, consists of 9 subtests from which 4 summary indexes can be calculated: verbal memory index, visual memory index, learning index, and general memory index. During this test the investigator pointed to a longer and longer series of windows on a card at the rate of 1 location per second, and then the child was asked to reproduce the sequence exactly. One point was given for each correctly recalled sequence, and the test was discontinued after 3 consecutive errors.
    End point type
    Secondary
    End point timeframe
    Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [21]
    71 [22]
    Units: Correct Sequences
        arithmetic mean (standard deviation)
    12.9 ± 3.96
    14.3 ± 3.64
    Notes
    [21] - ITT Population
    [22] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score

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    End point title
    		 Hour 5.5 Test of Variables of Attention (TOVA) Commissions Standard Score
    End point description
    The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.
    End point type
    Secondary
    End point timeframe
    Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [23]
    71 [24]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    86.42 ± 33.261
    92.58 ± 34.545
    Notes
    [23] - ITT Population
    [24] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards

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    End point title
    		 Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Backwards
    End point description
    Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).
    End point type
    Secondary
    End point timeframe
    Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [25]
    71 [26]
    Units: Correct Trials
        arithmetic mean (standard deviation)
    5.1 ± 1.97
    5.4 ± 2.12
    Notes
    [25] - ITT Population
    [26] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient

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    End point title
    		 Hour 8.75 Gray Silent Reading Test (GSRT) Reading Quotient
    End point description
    Gray Silent Reading Test (GSRT)Reading Quotient is a reliable, validated measure of reading comprehension administered in the group setting during the first half hour of the homework session (range: 0,unbounded). A higher score is preferable as it means more questions were answered correctly.
    End point type
    Secondary
    End point timeframe
    Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [27]
    71 [28]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    85.9 ± 23.6
    91.9 ± 18.49
    Notes
    [27] - ITT Population
    [28] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score

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    End point title
    		 Hour 7.5 Test of Handwriting Skills (Revised) (THS-R) Standard Score
    End point description
    The THS-R (range: unbounded) is a standardized, untimed assessment designed to evaluate neurosensory integration manifested in manuscript and cursive writing. The test includes subtests: writing from memory or dictation the letters of the alphabet in order, single digit-numbers out of order, selected words, and copying selected letters, words, and sentences. Each subtest was scored from zero (poorly formed letters) to 3 (perfectly formed letters). 100 is the normal mean; scores lower than 100 indicate performance worse than normal, scores above 100 indicate performance better than normal.
    End point type
    Secondary
    End point timeframe
    Hour 7.5 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [29]
    71 [30]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    93.6 ± 20.77
    98.3 ± 21.81
    Notes
    [29] - ITT Population
    [30] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)

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    End point title
    		 Hour 3.5 Dynamic Indicators of Basic Early Literacy Skills (DIBELS)
    End point description
    The DIBELS (range: 0, 376), used to assess reading fluency, consists of standardized, individually administered measures of early literacy development. These short (1 minute) fluency measures were developed based upon essential early literacy domains to assess development of phonological awareness, alphabetic understanding, and automaticity and fluency. Only the paragraph fluency component of an age/grade-appropriate DIBELS was used. A higher score indicated better performance, as it represented that the subject orally read a greater number of words correctly within the time allowed.
    End point type
    Secondary
    End point timeframe
    Hour 3.5 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [31]
    71 [32]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    106.2 ± 35.15
    112 ± 35.51
    Notes
    [31] - ITT Population
    [32] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards

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    End point title
    		 Hour 5.5 Wechsler Intelligence Scale for Children - 3rd ed. (WISC-III-PI) Digit Span Forwards
    End point description
    Each child individually was given a sequence of numbers with the sequence becoming progressively longer. The child was then asked to repeat the digits in the same sequence, either forwards or backwards. Each sequence length was attempted twice. The test was complete after failure on both trials of any sequence length. One point was awarded if the participant passed only 1 trial of a sequence length. Zero points were given if the participant failed both trials. The maximum raw scores were 16 forwards and 14 backwards. A higher score was indicative of better recall and attention (range: 0, 14).
    End point type
    Secondary
    End point timeframe
    Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [33]
    71 [34]
    Units: Correct Trials
        arithmetic mean (standard deviation)
    9.2 ± 1.88
    9.3 ± 1.7
    Notes
    [33] - ITT Population
    [34] - ITT population
    No statistical analyses for this end point

    Secondary: Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score

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    End point title
    		 Hour 5.5 Test of Variables of Attention (TOVA) Omissions Standard Score
    End point description
    The TOVA (range: unbounded) is a computerized, visual continuous performance test providing a measure of attention. The stimulus, presented for 100 milliseconds (ms) at the rate of 30 per minute, is a computer-presented square containing a square hole near the top (target) or bottom (non-target) edge. Higher scores indicated better performance, lower scores indicate worse performance. Clinical interpretation: scores below 80 are considered abnormal, 80-85 are considered borderline, and scores above 85 are considered within normal limits.
    End point type
    Secondary
    End point timeframe
    Hour 5.5 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [35]
    71 [36]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    25.98 ± 126.281
    64.07 ± 88.77
    Notes
    [35] - ITT population
    [36] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 3.0 Grammar Task

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    End point title
    		 Hour 3.0 Grammar Task
    End point description
    This task, presented once during a laboratory school day, was designed to index “attention to detail” by determining how many grammatical mistakes each child could identify and circle in a brief paragraph. The errors were not difficult to identify and were designed to show attention to task, not comprehension. A higher number of errors identified, of those possible, was indicative of better attention - identification of grammatical errors(range: 0, 1 represents correct responses divided by the number of possible responses).
    End point type
    Secondary
    End point timeframe
    Hour 3.0 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [37]
    71 [38]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.241 ± 0.1704
    0.327 ± 0.2204
    Notes
    [37] - ITT Population
    [38] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 8.75 Packet Activity Short Story With Questions for Comprehension

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    End point title
    		 Hour 8.75 Packet Activity Short Story With Questions for Comprehension
    End point description
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
    End point type
    Secondary
    End point timeframe
    Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [39]
    71 [40]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.609 ± 0.2449
    0.629 ± 0.2843
    Notes
    [39] - ITT Population
    [40] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 8.75 Packet Activity Identify Root Word

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    End point title
    		 Hour 8.75 Packet Activity Identify Root Word
    End point description
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
    End point type
    Secondary
    End point timeframe
    Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [41]
    71 [42]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.744 ± 0.3058
    0.76 ± 0.3054
    Notes
    [41] - ITT Population
    [42] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 8.75 Packet Activity Alphabetize List of Words

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    End point title
    		 Hour 8.75 Packet Activity Alphabetize List of Words
    End point description
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
    End point type
    Secondary
    End point timeframe
    Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [43]
    71 [44]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.676 ± 0.34
    0.676 ± 0.3369
    Notes
    [43] - ITT Population
    [44] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 8.75 Packet Activity Identify Multiple Meanings for Words

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    End point title
    		 Hour 8.75 Packet Activity Identify Multiple Meanings for Words
    End point description
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
    End point type
    Secondary
    End point timeframe
    Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [45]
    71 [46]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.694 ± 0.3123
    0.795 ± 0.3019
    Notes
    [45] - ITT Population
    [46] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 8.75 Packet Activity Complete Sentences Using Words Provided

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    End point title
    		 Hour 8.75 Packet Activity Complete Sentences Using Words Provided
    End point description
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
    End point type
    Secondary
    End point timeframe
    Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [47]
    71 [48]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.652 ± 0.3251
    0.741 ± 0.3221
    Notes
    [47] - ITT Population
    [48] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 8.75 Packet Activity Word Search

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    End point title
    		 Hour 8.75 Packet Activity Word Search
    End point description
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses)
    End point type
    Secondary
    End point timeframe
    Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [49]
    71 [50]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.935 ± 0.1952
    0.979 ± 0.1123
    Notes
    [49] - ITT Population
    [50] - ITT Population
    No statistical analyses for this end point

    Secondary: Hour 8.75 Packet Activity Decode the Mystery Sentence

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    End point title
    		 Hour 8.75 Packet Activity Decode the Mystery Sentence
    End point description
    Packet Activities: Assessment of ability to organize, listen to instructions, initiate task, complete task, and distractibility, by completing a word search, reading a short story for comprehension on a multiple choice test, reading a longer story for comprehension on a true/false test, decoding a mystery sentence, and completing various vocabulary assessments (word choice, homophones; base/root words, alphabetic order) (range: 0, 1 represents correct responses divided by the number of possible responses).
    End point type
    Secondary
    End point timeframe
    Hour 8.75 of the Lab School Day During the Double-Blind Assessment Period
    End point values
    		 Placebo Concerta
    Number of subjects analysed
    71 [51]
    71 [52]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.96 ± 0.1566
    0.987 ± 0.0501
    Notes
    [51] - ITT Population
    [52] - ITT Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to End of treatment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Concerta (Open-Label Dose Adjustment Period)
    Reporting group description
    		 Subjects initiated with Concerta as 18 milligram/day (mg/day) once daily. Concerta dose was continuously increased until an optimal individualized dose was achieved, up to a maximum dose of 54 mg/day.

    Reporting group title
    Placebo/Concerta
    Reporting group description
    		 Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54 mg tablet) once daily at lab school day 2

    Reporting group title
    Concerta/Placebo
    Reporting group description
    		 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

    Serious adverse events
    		 Concerta (Open-Label Dose Adjustment Period) Placebo/Concerta Concerta/Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Concerta (Open-Label Dose Adjustment Period) Placebo/Concerta Concerta/Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    20 / 36 (55.56%)
    15 / 35 (42.86%)
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 36 (8.33%)
    0 / 35 (0.00%)
         occurrences all number
    0
    4
    0
    Fatigue
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 36 (5.56%)
    1 / 35 (2.86%)
         occurrences all number
    0
    4
    1
    Irritability
         subjects affected / exposed
    0 / 7 (0.00%)
    8 / 36 (22.22%)
    3 / 35 (8.57%)
         occurrences all number
    0
    9
    4
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 36 (5.56%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    2
    Thirst
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal Congestion
         subjects affected / exposed
    0 / 7 (0.00%)
    4 / 36 (11.11%)
    1 / 35 (2.86%)
         occurrences all number
    0
    4
    1
    Cough
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    2
    1
    Pulmonary Congestion
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 36 (5.56%)
    1 / 35 (2.86%)
         occurrences all number
    0
    2
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    2
    Psychiatric disorders
    Affective Disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 36 (5.56%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    Aggression
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Anger
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Depressed Mood
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Emotional Disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 36 (5.56%)
    1 / 35 (2.86%)
         occurrences all number
    0
    2
    2
    Impulse-Control Disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Initial Insomnia
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 36 (8.33%)
    3 / 35 (8.57%)
         occurrences all number
    0
    3
    3
    Logorrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    2
    Mental Status Changes
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Mood Swings
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 36 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    2
    Onychophagia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    2
    Sleep Terror
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Social Avoidant Behaviour
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Stereotypy
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    3
    Trichotillomania
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Investigations
    Weight Decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Contusion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Joint Sprain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 36 (8.33%)
    1 / 35 (2.86%)
         occurrences all number
    0
    3
    1
    Mental Impairment
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    1
    Headache
         subjects affected / exposed
    0 / 7 (0.00%)
    4 / 36 (11.11%)
    7 / 35 (20.00%)
         occurrences all number
    0
    5
    11
    Paraesthesia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Tremor
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 7 (0.00%)
    5 / 36 (13.89%)
    8 / 35 (22.86%)
         occurrences all number
    0
    6
    9
    Defaecation Urgency
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    2
    Dyspepsia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Frequent Bowel Movements
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    1 / 35 (2.86%)
         occurrences all number
    0
    1
    2
    Nausea
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 36 (5.56%)
    1 / 35 (2.86%)
         occurrences all number
    0
    2
    1
    Vomiting
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 36 (5.56%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Urinary Incontinence
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in Extremity
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 36 (2.78%)
    0 / 35 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 7 (0.00%)
    9 / 36 (25.00%)
    8 / 35 (22.86%)
         occurrences all number
    0
    10
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Oct 2008
    The first protocol amendment included removal of single-centre text and clarification that subscale scores could be considered to 1) allow subjects with 1 subtype of ADHD (attention deficit hyperactivity disorder) predominating and 2) be used in dose adjustments. Inclusion criteria#4 was updated and visit1 and visit 2 were included. Exclusion criteria #5 changed score to 3, clarified text. Dosage and administration was updated and subscales were allowed for dose adjustments.
    11 Dec 2008
    The second protocol amendment included clarification about optimal dose as both total and subscale scores ≤ 75th percentile, Laboratory assessment days shortened to 1 month (28 days) from 6 weeks, In inclusion criteria #2 name of Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K- SADS PL) was corrected

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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