Trial · NCT00546910

Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT00546910, Phase 4, Completed, Eli Lilly and Company; results first posted 2010-06-23

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT00546910. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00546910

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
NCT number: NCT00546910
Status: Completed
Phases: Phase 4
Enrollment: 125 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Attention Deficit Hyperactivity Disorder
Interventions: Atomoxetine, Placebo
First posted: 2007-10-19
Last updated: 2010-08-10
Results first posted: 2010-06-23

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Baseline, 8 weeks (W8)	Infra-red camera tracks movement of head reflector on patient performing computer test. Hyperactivity test variables: TA=percent time patient moved\>1 centimeter (cm)/second; DIS=path of movement (m); AR=total area (cm2) of movements; ME=number of position changes\>1 mm; MS=degree (percent) of directional changes. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation (SD)=1 in general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.
Primary	Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8	Baseline, 8 weeks	Computer test. Patient is to press button if target appears, but not at non-target. Inattention test variables: mRT=average time (ms) from target presentation to response; RTV=standard deviation of mRT; nVRT=RTV expressed in terms of RT (variation as a percent of mean value); OE= percent of omitted targets. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and SD=1 in the general population, expressing the probability determined by the Gamma function in terms of SD of Gaussian density). Higher scores reflect more severe symptoms.
Primary	Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8	Baseline, 8 weeks	Computer test. Patient is to press button if target appears, but not at non-target. Impulsivity variables during test: CE=percent of response to non-target; ANT=percent of responses prior to target presentation. Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.
Primary	Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8	Baseline, 8 weeks	Computer test. Patient is to press button if target appears, but not at non-target. Other variables during test: ER=percent of overall incorrect responses (CE and OE); MR=percent of multiple responses per presentation of target (patient responds more than once to target). Results are converted to Q-scores (age and sex-adjusted normalized scores with a mean=0 and standard deviation=1 in the general population, expressing the probability determined by the Gamma function in terms of standard deviation of Gaussian density). Higher scores reflect more severe symptoms.
Secondary	Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8	Baseline, 8 weeks	Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54.
Secondary	Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8	Baseline, 8 weeks	CGI-S-ADHD measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Secondary	Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8	Baseline, 8 weeks	Weekly Rating Of Evening \& Morning Behavior-Revised-Investigator Rated (WREMB-R-Inv) measures the level of difficulty of 11 common morning or evening behaviors (e.g. getting out of bed, doing homework, sitting through dinner). Possible scores for each item range from 0 (no difficulty) to 3 (a lot of difficulty) with a Total score (maximum score=33), Morning subscore (maximum score=9), Evening subscore (maximum score=24), and Item 11 score which pertains to degree of difficulty falling asleep (maximum score=3).

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Baseline, 8 weeks (W8)	Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.	Q-scores	MEAN
SECONDARY	Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8	Baseline, 8 weeks	Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.	units on a scale	MEAN
SECONDARY	Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8	Baseline, 8 weeks	Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.	units on a scale	MEAN
SECONDARY	Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8	Baseline, 8 weeks	Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.	units on a scale	MEAN
PRIMARY	Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8	Baseline, 8 weeks	Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.	Q-scores	MEAN
PRIMARY	Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8	Baseline, 8 weeks	Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.	Q-scores	MEAN
PRIMARY	Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8	Baseline, 8 weeks	Full analysis population (N=125) including all randomized participants taking at least one dose of study medication.	Q-scores	MEAN

Source ClinicalTrials.gov

Results by group180

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Atomoxetine	Baseline: TA-Morning	0.62	Standard Deviation 1.27	Q-scores
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Placebo	Baseline: TA-Morning	0.84	Standard Deviation 0.84	Q-scores
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Atomoxetine	Baseline: TA- Noon	0.65	Standard Deviation 1.13	Q-scores
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Placebo	Baseline: TA- Noon	0.76	Standard Deviation 0.79	Q-scores
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Atomoxetine	Baseline: TA- Evening	0.66	Standard Deviation 1.26	Q-scores
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Placebo	Baseline: TA- Evening	0.85	Standard Deviation 0.83	Q-scores
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Atomoxetine	W8 Change: TA- Morning	-0.32	Standard Deviation 1.00	Q-scores
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Placebo	W8 Change: TA- Morning	0.06	Standard Deviation 0.84	Q-scores
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Atomoxetine	W8 Change: TA- Noon	-0.60	Standard Deviation 1.13	Q-scores
Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8	Placebo	W8 Change: TA- Noon	0.15	Standard Deviation 0.74	Q-scores

1 to 10 of 180Source ClinicalTrials.gov

See all 180 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Atomoxetine	63
Overall Study	STARTED	Placebo	62
Overall Study	COMPLETED	Atomoxetine	54
Overall Study	COMPLETED	Placebo	51
Overall Study	NOT COMPLETED	Atomoxetine	9
Overall Study	NOT COMPLETED	Placebo	11

Source ClinicalTrials.gov

Adverse events28

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	Gastrointestinal disorders	Atomoxetine	7	63	8
other	Abdominal pain	Gastrointestinal disorders	Placebo	2	62	2
other	Abdominal pain upper	Gastrointestinal disorders	Atomoxetine	2	63	2
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	3	62	3
other	Nausea	Gastrointestinal disorders	Atomoxetine	6	63	7
other	Nausea	Gastrointestinal disorders	Placebo	2	62	2
other	Vomiting	Gastrointestinal disorders	Atomoxetine	3	63	3
other	Vomiting	Gastrointestinal disorders	Placebo	2	62	2
other	Fatigue	General disorders	Atomoxetine	4	63	4
other	Fatigue	General disorders	Placebo	1	62	2

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Atomoxetine
Total, all-cause mortality	Placebo
Total, other adverse events	Atomoxetine	32	63
Total, other adverse events	Placebo	27	62
Total, serious adverse events	Atomoxetine	0	63
Total, serious adverse events	Placebo	0	62

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25019647	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Atomoxetine vs Placebo: serious adverse events

Source Trial comparisons

Tests1

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
Continuous Performance Test	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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