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Trial record 25 of 27 for:    Edivoxetine OR LY2216684

A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00922636
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Attention Deficit Hyperactivity Disorder
Interventions Drug: LY2216684
Drug: Methylphenidate
Drug: Placebo (tablet)
Drug: Placebo (capsule)
Enrollment 340
Recruitment Details  
Pre-assignment Details

Treatment phase: Participants were randomized to:

1 of 3 fixed-dose LY2216684 treatment arms, placebo, or extended-release methylphenidate (stimulant-naive stratum)

1 of 3 fixed-dose LY2216684 treatment arms or placebo only (stimulant-prior stratum) Optional Taper phase: Participants received study drug (at reduced dose) or placebo for 2 weeks

Arm/Group Title Methylphenidate Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase. Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding. Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding. Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Period Title: Overall Study
Started 36 78 76 75 75
Entered Optional Taper Phase 4 10 15 7 12
Completed 29 62 56 58 59
Not Completed 7 16 20 17 16
Reason Not Completed
Adverse Event             3             3             2             3             2
Lack of Efficacy             1             7             3             2             4
Sponsor Decision             0             0             2             0             0
Withdrawal by Subject             0             0             5             2             4
Protocol Violation             0             0             2             2             0
Entry Criteria Not Met             0             0             1             1             0
Parent/Caregiver Decision             2             4             3             5             2
Lost to Follow-up             1             2             2             2             4
Arm/Group Title Methylphenidate Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day) Total
Hide Arm/Group Description Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase. Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding. Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding. Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding. Total of all reporting groups
Overall Number of Baseline Participants 36 78 76 75 75 340
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 78 participants 76 participants 75 participants 75 participants 340 participants
9.92  (2.94) 11.37  (3.07) 11.90  (3.03) 12.59  (2.81) 11.47  (3.10) 11.63  (3.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 78 participants 76 participants 75 participants 75 participants 340 participants
Female
9
  25.0%
25
  32.1%
24
  31.6%
22
  29.3%
20
  26.7%
100
  29.4%
Male
27
  75.0%
53
  67.9%
52
  68.4%
53
  70.7%
55
  73.3%
240
  70.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 78 participants 76 participants 75 participants 75 participants 340 participants
Hispanic or Latino
9
  25.0%
20
  25.6%
21
  27.6%
20
  26.7%
19
  25.3%
89
  26.2%
Not Hispanic or Latino
27
  75.0%
58
  74.4%
55
  72.4%
55
  73.3%
56
  74.7%
251
  73.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 78 participants 76 participants 75 participants 75 participants 340 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
2
   2.6%
1
   1.3%
1
   1.3%
4
   1.2%
Asian
0
   0.0%
4
   5.1%
5
   6.6%
3
   4.0%
5
   6.7%
17
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  16.7%
8
  10.3%
9
  11.8%
10
  13.3%
12
  16.0%
45
  13.2%
White
25
  69.4%
60
  76.9%
55
  72.4%
57
  76.0%
50
  66.7%
247
  72.6%
More than one race
5
  13.9%
6
   7.7%
5
   6.6%
4
   5.3%
7
   9.3%
27
   7.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 78 participants 76 participants 75 participants 75 participants 340 participants
Canada 1 4 4 5 4 18
Mexico 0 0 1 0 1 2
Puerto Rico 2 3 4 2 3 14
Taiwan 0 4 5 3 4 16
United States 33 67 62 65 63 290
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 63 58 60 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-10.35  (1.52) -12.20  (1.63) -16.09  (1.53) -16.39  (1.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, LY2216684 (0.2 mg/kg/Day)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.
Method Mixed Models Analysis
Comments The Least Squares (LS) Mean Change is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.74
Estimation Comments The LS Mean difference was computed as treatment minus placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, LY2216684 (0.3 mg/kg/Day)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.
Method Mixed Models Analysis
Comments The Least Squares (LS) Mean Value is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.04
Estimation Comments The LS Mean difference was computed as treatment minus placebo.
2.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 26
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-19.46  (2.50)
3.Secondary Outcome
Title Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 13 9 7 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.10  (0.25) 0.35  (0.26) -0.21  (0.24) -0.46  (0.20)
4.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 3
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
NA [1]   (NA)
[1]
Sample size not able to be analyzed.
5.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 60 52 58 57
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Total Score -6.09  (1.43) -6.13  (1.53) -5.93  (1.46) -12.53  (1.49)
Language Subscale Score -5.87  (1.43) -6.75  (1.54) -6.07  (1.45) -12.5  (1.49)
Math Subscales Score -4.63  (1.67) -3.8  (1.79) -2.85  (1.7) -7.78  (1.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, LY2216684 (0.2 mg/kg/Day)
Comments Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.938
Comments Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.
Method Mixed Models Analysis
Comments Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, LY2216684 (0.3 mg/kg/Day)
Comments Gated secondary analysis for total score. If both LY2216684 groups (0.2 mg/kg/day and 0.3 mg/kg/day) were statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.027. If only 0.2 mg/kg/day or 0.3 mg/kg/day LY2216684 was statistically significantly superior than placebo for the primary endpoint, then gated secondary analysis was assessed at an alpha level of 0.023 for the corresponding group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Statistical significance was assessed at an alpha level of 0.027 with a Dunnett adjustment for multiple comparisons.
Method Mixed Models Analysis
Comments Least squares (LS) mean is from a restricted maximum likelihood-based, mixed model repeated measure (MMRM) analysis.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.44
Estimation Comments [Not Specified]
6.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Total Score -12.14  (2.30)
Language Subscale Score -12.24  (2.32)
Math Subscales Score -7.11  (2.68)
7.Secondary Outcome
Title Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 62 59 60 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.07  (0.15) -0.96  (0.16) -1.52  (0.15) -1.41  (0.16)
8.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 26
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.69  (0.25)
9.Secondary Outcome
Title Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population included all randomized participants with a post-baseline result, excluding data from participants whose data may have been compromised.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 63 59 60 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
3.05  (0.14) 3.01  (0.15) 2.54  (0.14) 2.53  (0.15)
10.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 26
Least Squares Mean (Standard Error)
Unit of Measure: Total Score
2.31  (0.23)
11.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 60 52 58 57
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Predominantly Hyperactive-Impulsive Type Total -8.70  (1.71) -6.30  (1.84) -12.94  (1.75) -15.69  (1.78)
Predominantly Inattentive Type Total Scale -10.71  (1.62) -8.32  (1.74) -10.99  (1.66) -16.99  (1.69)
12.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Predominantly Hyperactive-Impulsive Type Total -12.41  (2.64)
Predominantly Inattentive Type Total Scale -18.28  (2.63)
13.Secondary Outcome
Title Change From Baseline in the Swanson, Nolan and Pelham (SNAP-IV) Oppositional Defiant Disorder (ODD) Total Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 13 9 7 11
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.19  (0.16) 0.62  (0.18) -0.04  (0.17) -0.30  (0.13)
14.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 3
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.72  (0.38)
15.Secondary Outcome
Title Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Impairment Items Subscales-Total Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 60 52 58 57
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Schoolwork/Grades Score -0.49  (0.12) -0.35  (0.13) -0.53  (0.12) -0.81  (0.13)
Friendships/Relationships Score -0.43  (0.12) -0.00  (0.13) -0.22  (0.12) -0.65  (0.13)
Home Life Score -0.40  (0.12) -0.08  (0.13) -0.44  (0.13) -0.73  (0.13)
16.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Schoolwork/Grades Score -0.65  (0.19)
Friendships/Relationships Score -0.28  (0.20)
Home Life Score -0.44  (0.21)
17.Secondary Outcome
Title Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT). All randomized participants with a baseline and at least 1 post-baseline C-SSRS assessment.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 78 75 73 73
Measure Type: Number
Unit of Measure: Participants
Suicidal Ideation 1 1 5 2
Suicidal Behavior 0 0 0 0
Suicidal Acts 0 0 0 0
18.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Participants
Suicidal Ideation 1
Suicidal Behavior 0
Suicidal Acts 0
19.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 60 52 58 56
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
-9.35  (1.74) -5.00  (1.88) -12.60  (1.79) -12.41  (1.85)
20.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
-11.85  (2.76)
21.Secondary Outcome
Title Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 60 52 58 57
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Aggressive Behaviors Scale Score -5.52  (1.55) -3.32  (1.68) -8.09  (1.59) -11.01  (1.62)
Social Problems T-score -6.77  (1.52) -3.33  (1.63) -5.19  (1.55) -12.06  (1.58)
Violence Potential T-score -6.97  (1.36) -4.22  (1.46) -7.95  (1.39) -11.88  (1.42)
22.Secondary Outcome
Title Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS) Content Subscales - Total Score at Week 8 in Stimulant Naive Methylphenidate Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Aggressive Behaviors Scale Score -10.96  (2.43)
Social Problems T-score -2.12  (2.50)
Violence Potential T-score -9.58  (2.11)
23.Secondary Outcome
Title Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 30 32 32 26
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Achievement Section (n=3,3,4,3) -339.71  (0.00) 301.79  (0.00) -12.42  (0.00) 64.55  (0.00)
Discomfort Section (n=30,31,32,26) -1.29  (1.03) 0.99  (1.07) 1.10  (0.98) 2.39  (1.14)
Resilience Section (n=30,30,31,26) 1.90  (1.38) 0.21  (1.45) 1.62  (1.33) 1.28  (1.49)
Risks Section (n=30,30,31,26) -0.08  (1.20) -0.28  (1.27) 2.18  (1.16) 0.74  (1.32)
Satisfaction Section (n=30,32,32,26) -0.12  (1.43) -0.05  (1.44) 2.95  (1.35) 0.72  (1.55)
24.Secondary Outcome
Title Change From Baseline in the Child Health and Illness Profile-Adolescent Edition (CHIP-AE) Domain Scores at Week 8 in Stimulant Naive Methylphenidate Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 6
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Achievement Section (n=1) NA [1]   (NA)
Discomfort Section (n=6) -1.97  (2.47)
Resilience Section (n=6) -4.06  (3.21)
Risks Section (n=6) 2.01  (3.06)
Satisfaction Section (n=6) 2.19  (3.25)
[1]
Sample size not able to be analyzed.
25.Secondary Outcome
Title Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 28 16 19 29
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Achievement Standardized Score (n=27,14,19,26) 3.82  (1.65) 3.45  (2.48) 2.96  (2.08) 3.81  (1.70)
Comfort Standardized Score (n=28,16,19,29) 8.24  (1.69) 2.96  (2.45) 3.50  (2.17) 7.82  (1.72)
Resilience Standardized Score (n=28,16,19,29) 4.07  (1.96) 0.60  (2.82) 0.19  (2.53) 4.75  (1.98)
Risk Avoidance Standardized Score (n=28,16,19,29) 6.06  (1.73) 1.81  (2.57) 5.77  (2.20) 4.75  (1.74)
Satisfaction Standardized Score(n=28,16,19,29) 1.19  (1.72) -2.07  (2.50) -1.24  (2.27) 3.63  (1.72)
26.Secondary Outcome
Title Change From Baseline in the Child Health and Illness Profile - Child Edition (CHIP-CE) at Week 8 in Stimulant Naive Methylphenidate Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 18
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
Achievement Standardized Score (n=17) 5.21  (2.02)
Comfort Standardized Score (n=18) 4.06  (1.93)
Resilience Standardized Score (n=18) 5.10  (2.62)
Risk Avoidance Standardized Score (n=18) 6.97  (2.11)
Satisfaction Standardized Score(n=18) 1.90  (2.40)
27.Secondary Outcome
Title Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Letter-Number Sequencing Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 56 50 55 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.30  (0.31) 1.36  (0.33) 1.48  (0.32) 1.84  (0.33)
28.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 23
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
1.58  (0.50)
29.Secondary Outcome
Title Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 28 26 30 23
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Objects (n=21,18,18,11) -0.56  (2.35) 6.45  (2.42) 11.70  (2.59) 5.64  (3.61)
Colors (n=25, 21, 26, 16) 2.85  (1.76) 4.86  (1.99) 3.30  (1.82) 2.98  (2.25)
Numbers (n=28, 26, 30, 23) 3.44  (1.14) 2.85  (1.25) 2.99  (1.09) 2.38  (1.26)
Letters (n=27,24,27,22) 1.16  (1.37) 2.84  (1.57) 3.62  (1.57) 2.22  (1.80)
2-set Letters and Numbers (n=27, 23, 28, 19) 5.23  (1.58) 3.21  (1.60) 6.38  (1.61) 4.69  (1.91)
3-set Letters, Numbers, and Colors (n=26,24,28,21) 7.89  (1.90) 3.86  (1.92) 6.47  (1.82) 1.56  (2.18)
30.Secondary Outcome
Title Change From Baseline in the Rapid Automatized Naming/Rapid Alternating Stimulus Test (RAN/RAS) Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 14
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Objects (n=9) 0.65  (4.88)
Colors (n=11) 3.37  (2.94)
Numbers (n=14) 6.60  (2.16)
Letters (n=11) 7.81  (2.70)
2-set Letters and Numbers (n=12) 6.65  (2.57)
3-set Letters, Numbers, and Colors (n=12) 4.82  (2.91)
31.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 60 52 58 57
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
-7.17  (1.52) -4.00  (1.64) -10.18  (1.57) -12.29  (1.59)
32.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
-13.83  (2.54)
33.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 60 52 58 57
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
CBRS Generalized Anxiety Disorder T-score -9.09  (1.46) -5.34  (1.57) -11.07  (1.50) -15.39  (1.53)
CBRS Separation Anxiety Disorder Scale T-score -6.71  (1.48) -1.13  (1.59) -5.88  (1.52) -8.60  (1.54)
34.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
CBRS Generalized Anxiety Disorder T-score -8.78  (2.40)
CBRS Separation Anxiety Disorder Scale T-score -2.91  (2.66)
35.Secondary Outcome
Title Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Conduct Disorder Symptom Subscale Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 60 52 58 57
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
-4.64  (1.43) -2.24  (1.55) -6.26  (1.48) -7.62  (1.50)
36.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
-7.10  (2.27)
37.Secondary Outcome
Title Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Major Depressive Episode Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 60 52 58 57
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
-10.27  (1.56) -5.41  (1.68) -9.58  (1.59) -13.67  (1.62)
38.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Error)
Unit of Measure: T-Score
-1.09  (2.38)
39.Secondary Outcome
Title Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Total Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 63 58 59 57
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.95  (0.83) -4.72  (0.89) -7.08  (0.84) -8.24  (0.87)
40.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 25
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.88  (1.45)
41.Secondary Outcome
Title Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R) Morning Summary Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 63 58 59 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.07  (0.28) -0.91  (0.30) -1.53  (0.29) -2.20  (0.29)
42.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 26
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.80  (0.44)
43.Secondary Outcome
Title Change From Baseline in the Weekly Parent Ratings of Evening and Morning Behavior-Revised (WPREMB-R ) Evening Summary Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 63 58 60 58
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.34  (0.58) -3.37  (0.61) -4.77  (0.58) -5.24  (0.60)
44.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 25
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.17  (1.04)
45.Secondary Outcome
Title Change From Baseline in the Conners' Comprehensive Behavior Rating Scale (CP-CBRS DSM-IV-TR) Mixed Episode Score at Week 8
Hide Description The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
46.Secondary Outcome
Title 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
Hide Description The mixed episode score does not exist in the Conners CBRS scale; therefore no analyses could be conducted.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No participants had data analyzed because the mixed episode score does not exist in the outcome measure; therefore, no analyses could be conducted.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
47.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 63 59 60 59
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Hyperactivity-Impulsivity Score (n=63, 58,60,59) -4.88  (0.79) -5.94  (0.84) -7.53  (0.80) -7.32  (0.81)
Inattention Score (n=63, 59, 60, 59) -5.55  (0.92) -6.23  (0.98) -8.58  (0.92) -9.09  (0.94)
48.Secondary Outcome
Title Change From Baseline in the ADHDRS-IV-Parent:Inv Hyperactivity-Impulsivity and Inattention Subtotal Scores at Week 8 in Stimulant Naive Methylphenidate Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 26
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Hyperactivity-Impulsivity Score -9.00  (1.29)
Inattention Score -10.46  (1.46)
49.Secondary Outcome
Title Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Total Score at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 56 51 56 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.64  (0.30) 1.22  (0.32) 0.95  (0.30) 1.02  (0.32)
50.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.54  (0.47)
51.Secondary Outcome
Title Change From Baseline in the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV) Digit Span Subtotal Scores at Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 56 51 56 51
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Digit Span Forward: Scaled Process Score 0.43  (0.31) 0.97  (0.33) 0.56  (0.31) 0.61  (0.33)
Digit Span Backward: Scaled Process Score 0.77  (0.34) 0.98  (0.37) 1.04  (0.35) 0.74  (0.37)
52.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 24
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Digit Span Forward: Scaled Process Score 0.53  (0.50)
Digit Span Backward: Scaled Process Score 0.36  (0.52)
53.Secondary Outcome
Title Number of Participants With a Response (Response Rate) up to Week 8
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo LY2216684 (0.1 mg/kg/Day) LY2216684 (0.2 mg/kg/Day) LY2216684 (0.3 mg/kg/Day)
Hide Arm/Group Description:
Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
Overall Number of Participants Analyzed 63 58 60 59
Measure Type: Number
Unit of Measure: Participants
22 19 34 28
54.Secondary Outcome
Title Number of Participants With a Response (Response Rate) up to Week 8 in Stimulant Naive Methylphenidate Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Methylphenidate
Hide Arm/Group Description:
Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: Participants
14
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo - Treatment Phase LY2216684 (0.1 mg/kg/Day) - Treatment Phase LY2216684 (0.2 mg/kg/Day) - Treatment Phase LY2216684 (0.3 mg/kg/Day) - Treatment Phase Methylphenidate - Treatment Phase Placebo - Taper Phase LY2216684 (0.1 mg/kg/Day) - Taper Phase LY2216684 (0.2 mg/kg/Day) - Taper Phase LY2216684 (0.3 mg/kg/Day) - Taper Phase Methylphenidate - Taper Phase
Hide Arm/Group Description Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase. Participants were given 0.1 milligrams per kilogram per day (mg/kg/day) of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding. Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding. Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding. Participants were given 18 mg/day to 54 mg/day of extended-release methylphenidate capsules, based on weight QD po for the 8-week double-blind treatment phase. Participants were also given placebo tablets to maintain LY2216684 blinding. Methylphenidate blind: Participants were given the placebo in capsule form QD po for the 2-week taper phase. Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase. Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in taper phase. Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase. Participants were given the placebo in capsule form QD po for the 2-week taper phase.
All-Cause Mortality
Placebo - Treatment Phase LY2216684 (0.1 mg/kg/Day) - Treatment Phase LY2216684 (0.2 mg/kg/Day) - Treatment Phase LY2216684 (0.3 mg/kg/Day) - Treatment Phase Methylphenidate - Treatment Phase Placebo - Taper Phase LY2216684 (0.1 mg/kg/Day) - Taper Phase LY2216684 (0.2 mg/kg/Day) - Taper Phase LY2216684 (0.3 mg/kg/Day) - Taper Phase Methylphenidate - Taper Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo - Treatment Phase LY2216684 (0.1 mg/kg/Day) - Treatment Phase LY2216684 (0.2 mg/kg/Day) - Treatment Phase LY2216684 (0.3 mg/kg/Day) - Treatment Phase Methylphenidate - Treatment Phase Placebo - Taper Phase LY2216684 (0.1 mg/kg/Day) - Taper Phase LY2216684 (0.2 mg/kg/Day) - Taper Phase LY2216684 (0.3 mg/kg/Day) - Taper Phase Methylphenidate - Taper Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/78 (0.00%)      0/76 (0.00%)      0/75 (0.00%)      0/75 (0.00%)      0/36 (0.00%)      0/10 (0.00%)      0/15 (0.00%)      0/7 (0.00%)      0/12 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo - Treatment Phase LY2216684 (0.1 mg/kg/Day) - Treatment Phase LY2216684 (0.2 mg/kg/Day) - Treatment Phase LY2216684 (0.3 mg/kg/Day) - Treatment Phase Methylphenidate - Treatment Phase Placebo - Taper Phase LY2216684 (0.1 mg/kg/Day) - Taper Phase LY2216684 (0.2 mg/kg/Day) - Taper Phase LY2216684 (0.3 mg/kg/Day) - Taper Phase Methylphenidate - Taper Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/78 (65.38%)      58/76 (76.32%)      59/75 (78.67%)      49/75 (65.33%)      30/36 (83.33%)      1/10 (10.00%)      4/15 (26.67%)      0/7 (0.00%)      0/12 (0.00%)      0/4 (0.00%)    
Gastrointestinal disorders                     
Abdominal pain upper  1  7/78 (8.97%)  8 14/76 (18.42%)  16 3/75 (4.00%)  3 11/75 (14.67%)  16 8/36 (22.22%)  9 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Diarrhoea  1  2/78 (2.56%)  2 5/76 (6.58%)  5 3/75 (4.00%)  3 1/75 (1.33%)  1 0/36 (0.00%)  0 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Nausea  1  4/78 (5.13%)  4 5/76 (6.58%)  6 13/75 (17.33%)  18 10/75 (13.33%)  10 3/36 (8.33%)  3 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Vomiting  1  3/78 (3.85%)  3 7/76 (9.21%)  8 9/75 (12.00%)  10 10/75 (13.33%)  11 1/36 (2.78%)  1 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
General disorders                     
Fatigue  1  3/78 (3.85%)  3 3/76 (3.95%)  3 3/75 (4.00%)  3 3/75 (4.00%)  3 4/36 (11.11%)  4 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Irritability  1  4/78 (5.13%)  4 10/76 (13.16%)  10 7/75 (9.33%)  7 5/75 (6.67%)  5 6/36 (16.67%)  6 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Infections and infestations                     
Gastroenteritis  1  0/78 (0.00%)  0 0/76 (0.00%)  0 0/75 (0.00%)  0 0/75 (0.00%)  0 2/36 (5.56%)  2 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Nasopharyngitis  1  3/78 (3.85%)  3 1/76 (1.32%)  1 4/75 (5.33%)  4 1/75 (1.33%)  1 1/36 (2.78%)  1 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Upper respiratory tract infection  1  5/78 (6.41%)  5 7/76 (9.21%)  8 4/75 (5.33%)  4 3/75 (4.00%)  3 2/36 (5.56%)  2 0/10 (0.00%)  0 1/15 (6.67%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Investigations                     
Blood creatine phosphokinase increased  1  0/78 (0.00%)  0 0/76 (0.00%)  0 1/75 (1.33%)  1 1/75 (1.33%)  1 0/36 (0.00%)  0 0/10 (0.00%)  0 1/15 (6.67%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Heart rate increased  1  0/78 (0.00%)  0 2/76 (2.63%)  2 0/75 (0.00%)  0 4/75 (5.33%)  4 1/36 (2.78%)  1 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Urine leukocyte esterase positive  1  0/78 (0.00%)  0 0/76 (0.00%)  0 0/75 (0.00%)  0 0/75 (0.00%)  0 0/36 (0.00%)  0 0/10 (0.00%)  0 1/15 (6.67%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Weight decreased  1  0/78 (0.00%)  0 0/76 (0.00%)  0 1/75 (1.33%)  1 0/75 (0.00%)  0 4/36 (11.11%)  4 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Metabolism and nutrition disorders                     
Decreased appetite  1  3/78 (3.85%)  3 6/76 (7.89%)  6 10/75 (13.33%)  10 8/75 (10.67%)  9 17/36 (47.22%)  17 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Nervous system disorders                     
Dizziness  1  7/78 (8.97%)  7 4/76 (5.26%)  6 6/75 (8.00%)  7 5/75 (6.67%)  5 3/36 (8.33%)  3 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Headache  1  12/78 (15.38%)  16 11/76 (14.47%)  13 14/75 (18.67%)  16 9/75 (12.00%)  16 7/36 (19.44%)  7 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Sedation  1  1/78 (1.28%)  1 4/76 (5.26%)  4 7/75 (9.33%)  7 4/75 (5.33%)  4 3/36 (8.33%)  3 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Somnolence  1  5/78 (6.41%)  5 4/76 (5.26%)  6 14/75 (18.67%)  15 4/75 (5.33%)  4 0/36 (0.00%)  0 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Psychiatric disorders                     
Affect lability  1  0/78 (0.00%)  0 0/76 (0.00%)  0 0/75 (0.00%)  0 1/75 (1.33%)  1 2/36 (5.56%)  3 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Aggression  1  1/78 (1.28%)  1 1/76 (1.32%)  1 2/75 (2.67%)  2 2/75 (2.67%)  2 2/36 (5.56%)  2 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Depressed mood  1  0/78 (0.00%)  0 0/76 (0.00%)  0 0/75 (0.00%)  0 0/75 (0.00%)  0 2/36 (5.56%)  2 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Initial insomnia  1  2/78 (2.56%)  3 2/76 (2.63%)  3 1/75 (1.33%)  1 1/75 (1.33%)  1 2/36 (5.56%)  2 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Insomnia  1  5/78 (6.41%)  5 5/76 (6.58%)  5 4/75 (5.33%)  4 2/75 (2.67%)  2 7/36 (19.44%)  8 1/10 (10.00%)  1 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Mood altered  1  1/78 (1.28%)  1 1/76 (1.32%)  1 3/75 (4.00%)  3 2/75 (2.67%)  2 2/36 (5.56%)  2 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Sleep disorder  1  0/78 (0.00%)  0 0/76 (0.00%)  0 1/75 (1.33%)  1 0/75 (0.00%)  0 4/36 (11.11%)  5 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                     
Cough  1  4/78 (5.13%)  5 3/76 (3.95%)  3 1/75 (1.33%)  1 2/75 (2.67%)  2 4/36 (11.11%)  4 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Hiccups  1  0/78 (0.00%)  0 0/76 (0.00%)  0 0/75 (0.00%)  0 0/75 (0.00%)  0 0/36 (0.00%)  0 0/10 (0.00%)  0 1/15 (6.67%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Oropharyngeal pain  1  2/78 (2.56%)  2 2/76 (2.63%)  2 3/75 (4.00%)  3 0/75 (0.00%)  0 2/36 (5.56%)  2 0/10 (0.00%)  0 0/15 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Some sites may have received data with identifying information from the central lab; data from 69 participants were excluded from efficacy analyses. Data were excluded from efficacy analyses for a participant randomized before study site approval.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00922636     History of Changes
Other Study ID Numbers: 10925
H9P-MC-LNBF ( Other Identifier: Eli Lilly and Company )
First Submitted: June 16, 2009
First Posted: June 17, 2009
Results First Submitted: September 26, 2013
Results First Posted: August 18, 2014
Last Update Posted: August 18, 2014