A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00922636
First received: June 16, 2009
Last updated: July 29, 2014
Last verified: July 2014

June 16, 2009
July 29, 2014
June 2009
December 2010   (final data collection date for primary outcome measure)
  • Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) Total Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv)- mean change of total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00922636 on ClinicalTrials.gov Archive Site
  • Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Academic Difficulties Total Score and the Language and Math Subscales at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8) [ Time Frame: Weeks 1 through 8 ] [ Designated as safety issue: No ]
    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.
  • Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8) in Stimulant Naive Methylphenidate Group [ Time Frame: Weeks 1 through 8 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR ADHD) Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the CP-CBRS DSM-IV-TR ADHD Predominantly Hyperactive-Impulsive Type and Predominantly Inattentive Type Total Score and Symptom Scores at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Manic Episode - Total Score at 8 Weeks in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Symptom Subscale for Oppositional Defiant Disorder (ODD) Total Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Generalized Anxiety Disorder (GAD) and Separation Anxiety Disorder Symptom Subscales at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Mixed Episode Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.
  • Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Mixed Episode Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.
  • Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the ADHDRS-IV-Parent:Inv Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With a Response (Response Rate) up to Week 8 [ Time Frame: Baseline, up to 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With a Response (Response Rate) up to Week 8 in Stimulant Naive Methylphenidate Group [ Time Frame: Baseline, up to 8 weeks ] [ Designated as safety issue: No ]
    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.
  • Swanson Nolan, and Pelham (SNAP) ADHD - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS) academic difficulties - total/language/math subscale- mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)- mean change of total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Attention-Deficit/Hyperactivity Disorder-Improvement (CGI-ADHD-I)- endpoint score [ Time Frame: week 1, week 8 ] [ Designated as safety issue: No ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR ADHD) symptom subscales - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Swanson Nolan, and Pelham (SNAP-IV) oppositional defiant disorder (ODD) subscale; Teacher rated - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: Yes ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS) impairment items subscale- mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Columbia Suicide Severity Rating Scale (C-SSRS)- incident rate for each category [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: Yes ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for manic episode - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS) content subscales - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Child Health and Illness Profile-Adolescent edition (CHIP-AE) - mean change of each domain scores [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Child Health and Illness Profile-Child edition (CHIP-CE) - mean change of each domain scores [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing - change from baseline [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Rapid Automatized Naming/ Rapid Alternating Stimulus Test (RAN/RAS)- mean change of each subtotal score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for ODD - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: Yes ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for anxiety- mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: Yes ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for conduct disorder - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: Yes ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for major depressive episode- mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: Yes ]
  • Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R )- mean change of total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R )- mean change of a.m. total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R )- mean change of p.m. total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) symptom subscales for mixed episode- mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv)- mean change of total score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv)- mean change of subtotal scores [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  • Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span - mean change of total score [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
  • Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span - mean change of subtotal scores [ Time Frame: Baseline, week 4, week 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder
A Fixed-Dose, Randomized, Double-Blind, Placebo-Controlled Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder

The primary purpose of your child's participation in this study is to determine whether LY2216684 can help pediatric patients with attention-deficit/hyperactivity disorder (ADHD); and assess the safety of LY2216684 and any side effects that might be associated with it.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • Drug: LY2216684
    Taken in tablet form QD po.
    Other Name: Edivoxetine
  • Drug: Methylphenidate
    Extended-release methylphenidate 18 mg/day to 54 mg/day, based on weight, QD po as a capsule for the 8-week double-blind treatment phase.
  • Drug: Placebo (tablet)
    Placebo given as a tablet for LY2216684 blind QD po for the 8-week double-blind treatment phase, followed by 2 weeks in the taper phase.
  • Drug: Placebo (capsule)
    Placebo given as a capsule for methylphenidate blind QD po for the 8-week double-blind treatment phase followed by 2 weeks in the taper phase.
  • Active Comparator: Methylphenidate
    Extended-release methylphenidate 18 milligrams per day (mg/day) to 54 mg/day, based on weight, given once daily (QD) and orally (po) as a capsule for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the taper phase.
    Intervention: Drug: Methylphenidate
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo (tablet)
    • Drug: Placebo (capsule)
  • Experimental: LY2216684 (0.1 mg/kg/day)
    Taken in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the taper phase.
    Intervention: Drug: LY2216684
  • Experimental: LY2216684 (0.2 mg/kg/day)
    Taken in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the taper phase.
    Intervention: Drug: LY2216684
  • Experimental: LY2216684 (0.3 mg/kg/day)
    Taken in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the taper phase.
    Intervention: Drug: LY2216684
Lin DY, Kratochvil CJ, Xu W, Jin L, D'Souza DN, Kielbasa W, Allen AJ. A randomized trial of edivoxetine in pediatric patients with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2014 May;24(4):190-200. doi: 10.1089/cap.2013.0043.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
340
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD based on Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL) prior to randomization.
  • Patients must have an Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored (ADHD-RS-IV-PV:IR) total score at least 1.5 standard deviations above the age/gender norm prior to randomization. They must have a Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) score greater than or equal to 4 at both the patients screening visit, prior to randomization.
  • Patients must have laboratory results; showing no clinically significant abnormalities.
  • Patients must be of normal intelligence, as assessed by the investigator.
  • Patients/parents must have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venous punctures and examinations required by the protocol.
  • Patients of child-bearing potential agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug. Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test.

Exclusion Criteria:

  • Patients who weigh less than 18 kg or greater than 75 kg at screening and at randomization.
  • Female patients who are pregnant or who are breast-feeding. Patients who have a history of Bipolar I/ II, psychosis, or pervasive developmental disorder.
  • Patients who have current motor tics or a diagnosis of Tourette's Syndrome.
  • Patients with marked anxiety, tension, and agitation sufficient, to contraindicate treatment with extended-release methylphenidate.
  • Patients with a history of any seizure disorder, known electroencephalographic (EEG) abnormalities in the absence of seizures.
  • If the electrocardiogram (ECG) assessed at screening/prior to randomization shows an abnormality meeting one or more of the absolute exclusion criteria listed in the Pediatric ECG Alert Criteria must be excluded from the study.
  • Patients who, in the opinion of the investigator, are at serious suicidal risk.
  • Patients with a history of severe allergies to more than one class of medications, multiple adverse drug reactions, or known hypersensitivity to extended-release methylphenidate.
  • Patients with a history of alcohol or drug abuse within the past 3 months prior to, or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medication in a manner that the investigator considers indicative of abuse.
  • Patients who screen positive for drugs of abuse not prescribed by a physician cannot participate. Drug screen may be repeated at the discretion of the investigator, and the patient may be allowed to enter the study if the repeat screen is negative. All patients must have a negative drug screen before enrollment in the study.
  • Patients who have a medical condition that would increase sympathetic nervous system activity markedly, or who are taking a medication on a daily basis that has sympathomimetic activity are excluded. Such medications can be taken on an as-needed basis.
  • Patients with problems that would be exacerbated by increased norepinephrine tone, including a history of cardiovascular disease, thyroid dysfunction, glaucoma, urinary retention, or severe gastrointestinal narrowing.
  • Patients who, at any time during the study, are likely to need psychotropic medications apart from the drugs under study.
  • Patients who, at any time during the study, are likely to begin structured psychotherapy aimed at ADHD symptoms are excluded. Psychotherapy initiated at least 1 month prior to screening is acceptable.
  • Patients who have used a monoamine oxidase inhibitor (MAOI) during the 2 weeks prior to randomization.
  • Patients with current or past history of clinically significant hypertension.
  • Patients who are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an off-label use of an investigational drug, or concurrently enrolled in any other type of medical research.
  • Patients who have participated in a prior study of LY2216684.
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT00922636
10925, H9P-MC-LNBF
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP