Long-Term, Open-Label, Safety Study of LY2216684 in Pediatric Patients With Attention Deficit/Hyperactivity Disorder

简要总结

主要结局

次要结局

• Mean Change From Baseline Z-scores for Height(Baseline, Week 60; Baseline, Week 240)
• Number of Participants Who Discontinued Due to Any Reason(Baseline Through Week 252)
• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)(Baseline Through Week 252)
• Number of Participants With At Least One TEAE(Baseline Through Week 252)
• Percentage of Participants With Discontinuation Due to Adverse Events (DCAEs)(Baseline Through Week 252)
• Number of Participants With At Least One DCAEs(Baseline Through Week 252)
• Percentage of Participants Who Discontinued Due to Any Reason(Baseline Through Week 252)
• Percentage of Participants With Columbia-Suicide Severity Rating Scale (CSSRS) for Each Category(Baseline Through Week 252, Baseline, 1-month (mo) Follow-Up (f/u))
• Mean Change From Baseline Z-Score for Weight(Baseline, Week 60; Baseline, Week 240)
• Mean Change From Baseline Z-Score in Body Mass Index (BMI)(Baseline, Week 60; Baseline, Week 240)
• Number of Participants With a Response Rate(Week 12)
• Survival Curve Time to Response(Week 12)
• Percentage of Participants in Sexual Maturation on Tanners Scale(Baseline Up to Week 252)
• Number of Participants in Sexual Maturation on Tanners Scale(Baseline Up to Week 252)
• Percentage of Participants With Response Rates(Week 12)
• Mean Change From Baseline of Total Score SNAP-IV Oppositional Defiant Disorder (ODD) Subscale(Baseline, Week 12)
• Percentage of Participants With Tobacco, Alcohol and Marijuana Use(Week 60 through Week 252)
• Number of Participants With Tobacco, Alcohol and Marijuana Use(Week 60 through Week 252)
• Mean Change From Baseline of Each Score Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) (Hyperactive/Impulsive, Inattentive and Total Score)(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change From Baseline of Total Score Clinical Global Impressions-Attention-Deficit/Hyperactivity Disorder-Severity (CGI-ADHD-S)(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change of Total Score Teacher-rated Swanson Nolan, and Pelham Rating Scale-Revised (SNAP-IV) ADHD Subscales (Hyperactive/Impulsive, Inattentive and Total Score)(Baseline, Week 12)
• Mean Change From Baseline of Each Total Score Conners Comprehensive Behavior Rating Scales (CP-CBRS) Diagnostic and Statistical Manual of Mental Disorders, 4th Ed, Text Revision (DSM-IV-TR) for Symptom Subscales Manic Episode and Mixed Episode(Baseline, Week 60; Baseline, Week 252)
• Mean Change From Baseline of Each Total Score CP-CBRS (DSM-IV-TR) ADHD Symptom Subscales (Hyperactive/Impulsive and Inattentive)(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change From Baseline of Each Total Score CP-CBRS DSM-IV-TR for Oppositional Defiant Disorder (ODD), Anxiety, Conduct Disorder and Major Depressive Episode(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change From Baseline of Each Raw Score CP-CBRS Impairment Items Subscales for Schoolwork/Grades, Friendship/Relationships, and Home Life(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change From Baseline of Each Total Score CP-CBRS Content Subscale for Aggressive Behaviors, Academic Difficulties, Social Problems, and Violence Potential)(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Adolescent Edition (CHIP-AE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)(Baseline, Week 12; Baseline, Week 60; Baseline, Week 156)
• Mean Change From Baseline of the 5 Domain Scores Child Health and Illness Profile-Child Edition (CHIP-CE) in 5 Health Outcome Domains (Satisfaction, Comfort, Resilience, Risk Avoidance and Achievement)(Baseline, Week 12; Baseline, Week 60; Baseline, Week 156)
• Mean Change From Baseline of Total Score Euro-Qol Questionnaire - 5 Dimensions 3 Levels (EQ-5D-3L) Health State for Parent(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change From Baseline of Total Score EQ-5D-3L Visual Analog Scale (VAS) for Parent(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change of From Baseline Total Score EQ-5D-3L Health State for Child(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change of From Baseline Total Score EQ-5D-3L VAS for Child(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change From Baseline of Total Score EQ-5D-3L Health State for Adolescent(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change From Baseline of Total Score EQ-5D-3L VAS(Baseline, Week 12; Baseline, Week 60; Baseline, Week 252)
• Mean Change From Baseline of Total Score Woodcock Johnson III Test of Achievement ([WJ III ACH])(Baseline, Week 60)
• Mean Change From Baseline of Total Score Wide Range Achievement Test (WRAT 4)(Baseline, Week 60)
• Mean Change From Baseline of Total Score Wechsler Intelligence Scale for Children Fourth Edition (WISC-IV)(Baseline, Week 60)
• Mean Change From Baseline of Total Score Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)(Baseline, Week 60)