A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder

Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data might have been compromised.

Assesses 18 Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD diagnosis symptoms/severity in past week. Each item: 0 (none/never, rarely) to 3 (severe/very often). Total score ranges from 0 to 54. Higher total scores indicate greater illness severity. Change scores=Week 8 score-baseline score. LS Mean Change adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Measures ADHD diagnostic symptoms (0=none/never-3=severe/very often). Inattention=sum odd items; hyperactivity-impulsivity=sum even items (subtotal: 0-27). Total scores: 0-54. High score=greater illness severity. Missing data-imputation in manual was applied. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Assesses adolescent's health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least Squares (LS) Mean Change from analysis of covariance model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline score.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Assesses adolescent's health status/functioning level. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. Items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) calculated for all domains by adjusting raw scores based on established reference group mean, standard deviation (T-scores mean=50, standard deviation=10). Higher scores=better health. Least squares (LS) mean of the change from baseline to endpoint (week 8) is from an ANCOVA model. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline CHIP-AE domain score.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

76-item parent-rated assessment of child's health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of covariance model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

76-item parent-rated assessment of child's health status/functioning level. Most items assess frequency of activities/feelings (1=never, 5=always). Standard scores (T-scores) were calculated for all domains by adjusting raw scores based on an established reference group mean and standard deviation (T-scores mean=50, standard deviation=10). Higher scores denote improvement. Least Squares (LS) Mean Change is from an analysis of ANCOVA model that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), and baseline domain score.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Measures participant's overall ADHD symptom severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Higher scores represent greater illness severity. Change scores=Week 8 score-baseline score. The Least Squares (LS) Mean Change was based on the fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, as well as the continuous, fixed effects of baseline CGI-S score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline total score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

The CP-CBRS academic difficulties total/language/math subscale score is a measure of academic performance. Each subscale item score ranges from 0 (never, seldom) to 3 (very often, very frequently). Total score is expressed as T-score based on gender/age norms. Academic difficulties T-score range: 0-100. Higher T-scores denote greater academic difficulties. Change scores=Week 8 score-baseline score. Least Squares Mean Change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline total score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score, baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Assess aggressive behaviors, academic difficulties, social problems, violence potential. Individual subscale items range: 0=never to 3=very often. Total expressed as T-score based on gender/age norms (0-100). Change scores=Week 8 score-baseline score. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score, baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline total score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Assess conduct disorder symptom severity. Individual subscale items: 0 (never/seldom) - 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-score=greater conduct disorder. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Assess anxiety symptom severity. Individual subscale items: 0 (never, seldom) - 3 (very often/frequently). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater anxiety. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Assess depressive symptom severity. Individual subscale items range: 0 (never, seldom) to 3 (very often/frequently). Total expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater depression. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.

Time frame: Baseline, 8 weeks

Population: No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.

The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.

Time frame: Baseline, 8 weeks

Population: No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.

Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Measures manic symptom severity. Individual subscale items range: 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms (0-100). Higher T-scores=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Assess ODD symptom severity. Individual subscale items range from 0 (never) to 3 (very often/frequently). Total is expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Rates schoolwork/grades, friendships/relationships, home life functioning (0=never to 3=very often). Total score expressed as a T-score based on gender/age norms (range 0-100). Higher T-score=greater symptom severity. Change scores=Week 8 score-baseline score. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis; included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Measures ADHD symptom severity. Individual items on each subscale are scored from 0 (never) to 3 (very often). Total score expressed as T-score based on gender/age norms. Subscale total T-scores (0-100); higher T-scores=greater symptom severity. Least Squares Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline total score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Assesses ability to accurately and rapidly recognize and name visual symbols. The tests consist of rapid automatized naming tests (that is, Letters, Numbers, Objects, Colors) and 2 rapid alternating stimulus tests (that is, 2-Set Letters and Numbers; 3-Set Letters, Numbers, and Colors). Scores are based on the amount of time required to name all the stimulus items in each test section. Raw scores were converted to standard scores based on participant's age and conversion tables from manual (mean=100, standard deviation=15). Higher scores=better ability. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and the continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) participant population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Includes Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision ADHD criteria for inattention (items 1-9) and hyperactivity/impulsivity (items 11-19) symptom subsets. Item score: 0 (not at all) to 3 (very much) rating scale. Total score is average of 18 items. Higher total scores=greater ADHD symptoms. Least Squares Mean change is adjusted for fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and the continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline total score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Measures oppositional defiance disorder symptoms. Total scores range from 0 (not at all) to 3 (very much). Higher total scores represent greater ODD. Change scores=Week 8 score-baseline score. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline total score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Measures attention, concentration, sequencing, number facility, and auditory short-term memory. Digit forward and digit backward subscales each comprise 2 trials and 8 items. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure analysis. Model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

A working memory subtest of WISC-IV, a measure of attention; concentration; sequencing; number facility; and auditory short-term memory. Scaled scores range from 1 to 19. Higher scores denote better performance. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, as well as the continuous, fixed effects of baseline Digit Span total score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Working memory subtest. Task involves sequencing, mental manipulation, attention, short-term memory, visual spatial imaging, and processing speed; consists of 10 items, 3 trials each. Scaled scores range: 1 to 19. Higher scores denote better performance. Least Squares Mean Change from restricted maximum likelihood-based, mixed model repeated measure analysis that included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline evening score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Measures difficulty level of 8 common evening behaviors (for example, sit through dinner) from 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges: 0 to 24; higher scores indicate greater difficulty in evening behavior. Least Squares (LS) Mean Change is from restricted maximum likelihood-based, mixed model repeated measure analysis (MMRM) and included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline evening score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline morning score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Measures difficulty level of 3 common morning behaviors (for example, get out of bed) from 0 (no difficulty) to 3 (a lot of difficulty). Total score range is from 0 to 9; a higher score indicates greater difficulty in morning behavior. Least Squares (LS) Mean Change from restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline morning score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Parent-completed 11-item questionnaire (3 morning items, 8 evening items) on a scale of 0 (no difficulty) to 3 (a lot of difficulty). Total score ranges from 0 to 33; higher score=greater difficulty in evening and morning behavior. Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis and includes fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction, and continuous, fixed effects of baseline score and baseline score\*visit interaction.

Time frame: Baseline, 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction.

Time frame: Weeks 1 through 8

Population: Per protocol (PP) population included all randomized participants with a post-baseline result, excluding data from participants whose data may have been compromised.

Measures total improvement (or worsening) of a participant's ADHD symptoms from the beginning of treatment. Scores range from 1 (very much improved) to 7 (very much worsened). Lower scores represent greater improvement. Least Squares (LS) Mean Change for weeks 1-8 is from a restricted maximum likelihood-based, mixed model repeated measure analysis. The model included fixed class effects of treatment, pooled investigative site, strata (prior stimulant use status), visit, and treatment\*visit interaction.

Time frame: Weeks 1 through 8

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score \<=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54.

Time frame: Baseline, up to 8 weeks

Population: Per protocol (PP) population included all randomized participants with a baseline and at least 1 post-baseline result, excluding data from participants whose data may have been compromised.

Response rate analysis compared the frequency of response between LY2216684 treatment groups versus placebo for participants who had a final study period II (weeks 1-8) Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score \<=60% of their baseline total score. ADHD-RS-IV-PV:IR measures 18 symptoms in Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) ADHD diagnosis. Item scores range: 0 (none/never or rarely) to 3 (severe/very often). Total scores range: 0 to 54.

Time frame: Baseline, up to 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.

Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide.

Time frame: 8 weeks

Population: Intent to treat (ITT). All randomized participants with a baseline and at least 1 post-baseline C-SSRS assessment.

Captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a yes answer to any of 3 suicidal behavior questions: preparatory acts or behavior, aborted attempt, and interrupted attempt. Suicidal ideation: yes answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a yes answer to actual attempt or completed suicide, nonfatal suicide attempt, and completed suicide.

Time frame: 8 weeks

Population: Stimulant naive participants randomized to methylphenidate with a baseline and at least 1 post-baseline result but excluded the participants whose data may have been compromised.