Trial · NCT00922636
A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder
NCT00922636, Phase 2, Phase 3, Completed, Eli Lilly and Company; results first posted 2014-08-18
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ConductScience Library. A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder. Trials, record NCT00922636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00922636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pediatric Patients With Attention Deficit/Hyperactivity Disorder
- NCT number
- NCT00922636
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 340 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- LY2216684, Methylphenidate, Placebo (tablet), Placebo (capsule)
- First posted
- 2009-06-17
- Last updated
- 2014-08-18
- Results first posted
- 2014-08-18
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes54
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Baseline, 8 weeks | 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. |
| Primary | 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 | Baseline, 8 weeks | 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. |
| Secondary | Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 | Baseline, 8 weeks | 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. |
| Secondary | 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 | Baseline, 8 weeks | 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. |
| Secondary | 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 | Baseline, 8 weeks | 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. |
| Secondary | 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 | Baseline, 8 weeks | 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. |
| Secondary | Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8 | Baseline, 8 weeks | 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. |
| Secondary | 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 | Baseline, 8 weeks | 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. |
| Secondary | Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8) | Weeks 1 through 8 | 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. |
| Secondary | 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 | Weeks 1 through 8 | 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. |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 registered outcomesOutcomes54
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Baseline, 8 weeks | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 | Baseline, 8 weeks | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline, 8 weeks | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline, 8 weeks | 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. | T-Score | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline, 8 weeks | 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. | T-Score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale (CGI-ADHD-S) Total Score at Week 8 | Baseline, 8 weeks | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline, 8 weeks | 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. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale (CGI-ADHD-I) Endpoint Score During the Treatment Phase (Weeks 1-8) | Weeks 1 through 8 | Per protocol (PP) population included all randomized participants with a post-baseline result, excluding data from participants whose data may have been compromised. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Weeks 1 through 8 | 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. | Total Score | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline, 8 weeks | 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. | T-Score | LEAST_SQUARES_MEAN |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 outcomesResults by group255
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Placebo | -10.35 | Standard Error 1.52 | units on a scale | |
| 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 | LY2216684 (0.1 mg/kg/Day) | -12.20 | Standard Error 1.63 | units on a scale | |
| 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 | LY2216684 (0.2 mg/kg/Day) | -16.09 | Standard Error 1.53 | units on a scale | |
| 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 | LY2216684 (0.3 mg/kg/Day) | -16.39 | Standard Error 1.57 | units on a scale | |
| Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 | Placebo | 0.10 | Standard Error 0.25 | units on a scale | |
| Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 | LY2216684 (0.1 mg/kg/Day) | 0.35 | Standard Error 0.26 | units on a scale | |
| Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 | LY2216684 (0.2 mg/kg/Day) | -0.21 | Standard Error 0.24 | units on a scale | |
| Change From Baseline in the Swanson, Nolan and Pelham Questionnaire: Attention-Deficit/Hyperactivity Disorder Subscale (SNAP-IV: ADHD) Total Score at Week 8 | LY2216684 (0.3 mg/kg/Day) | -0.46 | Standard Error 0.20 | units on a scale | |
| 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 | Methylphenidate | NA | Standard Error NA | units on a scale | |
| 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 | Placebo | Total Score | -6.09 | Standard Error 1.43 | T-Score |
1 to 10 of 255Source ClinicalTrials.gov
See all 255 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methylphenidate | 36 | |
| Overall Study | STARTED | Placebo | 78 | |
| Overall Study | STARTED | LY2216684 (0.1 mg/kg/Day) | 76 | |
| Overall Study | STARTED | LY2216684 (0.2 mg/kg/Day) | 75 | |
| Overall Study | STARTED | LY2216684 (0.3 mg/kg/Day) | 75 | |
| Overall Study | Entered Optional Taper Phase | Methylphenidate | 4 | |
| Overall Study | Entered Optional Taper Phase | Placebo | 10 | |
| Overall Study | Entered Optional Taper Phase | LY2216684 (0.1 mg/kg/Day) | 15 | |
| Overall Study | Entered Optional Taper Phase | LY2216684 (0.2 mg/kg/Day) | 7 | |
| Overall Study | Entered Optional Taper Phase | LY2216684 (0.3 mg/kg/Day) | 12 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events280
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo - Treatment Phase | 7 | 78 | 8 |
| other | Abdominal pain upper | Gastrointestinal disorders | LY2216684 (0.1 mg/kg/Day) - Treatment Phase | 14 | 76 | 16 |
| other | Abdominal pain upper | Gastrointestinal disorders | LY2216684 (0.2 mg/kg/Day) - Treatment Phase | 3 | 75 | 3 |
| other | Abdominal pain upper | Gastrointestinal disorders | LY2216684 (0.3 mg/kg/Day) - Treatment Phase | 11 | 75 | 16 |
| other | Abdominal pain upper | Gastrointestinal disorders | Methylphenidate - Treatment Phase | 8 | 36 | 9 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo - Taper Phase | 0 | 10 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | LY2216684 (0.1 mg/kg/Day) - Taper Phase | 0 | 15 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | LY2216684 (0.2 mg/kg/Day) - Taper Phase | 0 | 7 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | LY2216684 (0.3 mg/kg/Day) - Taper Phase | 0 | 12 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Methylphenidate - Taper Phase | 0 | 4 | 0 |
1 to 10 of 280Source ClinicalTrials.gov
See all 280 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - Treatment Phase | ||
| Total, all-cause mortality | LY2216684 (0.1 mg/kg/Day) - Treatment Phase | ||
| Total, all-cause mortality | LY2216684 (0.2 mg/kg/Day) - Treatment Phase | ||
| Total, all-cause mortality | LY2216684 (0.3 mg/kg/Day) - Treatment Phase | ||
| Total, all-cause mortality | Methylphenidate - Treatment Phase | ||
| Total, all-cause mortality | Placebo - Taper Phase | ||
| Total, all-cause mortality | LY2216684 (0.1 mg/kg/Day) - Taper Phase | ||
| Total, all-cause mortality | LY2216684 (0.2 mg/kg/Day) - Taper Phase | ||
| Total, all-cause mortality | LY2216684 (0.3 mg/kg/Day) - Taper Phase | ||
| Total, all-cause mortality | Methylphenidate - Taper Phase |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24840045 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Letter-Number Sequencing Task | Secondary outcome | ConductCognition |
| Serial Naming Task | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00922636
GET https://conductscience.org/api/trials/v1/NCT00922636/registered?page=2