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CompletedNCT00546910Updated Aug 10, 2010Results posted

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

A Phase 4 interventional study of Atomoxetine and Placebo in Attention Deficit Hyperactivity Disorder, sponsored by Eli Lilly and Company. Completed at 16 sites in Germany. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2010-08-10.

Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
125
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured during once or bi-weekly visits, three times per visit-day, by a computer based Continuous Performance Test. Following an initial 3-28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 125 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 139 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female patients who are at least 6 years of age, and who will not have reached their 13th birthday
  • Diagnosis of ADHD
  • Normal intelligence
  • Able to swallow capsules

Exclusion criteria

Exclusion Criteria:

  • Weight less than 20 kg or more than 60 kg at study entry
  • Prior treatment with atomoxetine
  • History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
  • History of severe allergies or multiple adverse drug reactions
  • Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT prolongation, inherited cardiac disorders
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
125 participants (actual)

Study arms

  • Experimental
    Atomoxetine

    0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.

    Drug: Atomoxetine

  • Placebo comparator
    Placebo

    Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine

    Drug: Placebo

Interventions

  • DrugAtomoxetine

    A one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day. 3 capsules of study medication have to be taken once daily in the morning, with or without food.

    Also known as: LY139603

  • DrugPlacebo

    3 capsules of placebo have to be taken once daily in the morning, with or without food.

06

What researchers measure

Primary outcomes

  1. 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

    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.

    Time frame: Baseline, 8 weeks (W8)

  2. 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

    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.

    Time frame: Baseline, 8 weeks

  3. Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8

    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.

    Time frame: Baseline, 8 weeks

  4. Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8

    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.

    Time frame: Baseline, 8 weeks

Secondary outcomes

  1. 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

    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.

    Time frame: Baseline, 8 weeks

  2. Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8

    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).

    Time frame: Baseline, 8 weeks

  3. Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8

    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).

    Time frame: Baseline, 8 weeks

07

Results

Posted Jun 23, 2010

Participant flow

Participant flow — Overall Study
MilestoneAtomoxetinePlacebo
Started6362
Completed5451
Not completed911
Withdrew: Adverse event23
Withdrew: Lack of efficacy57
Withdrew: Physician decision01
Withdrew: Withdrawal by subject20

Outcome measures

PrimaryChange 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

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.

Time frame:
Baseline, 8 weeks (W8)
Reported as:
Mean · 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
Q-scoresAtomoxetinePlacebo
Baseline: TA-Morning0.62 ± 1.270.84 ± 0.84
Baseline: TA- Noon0.65 ± 1.130.76 ± 0.79
Baseline: TA- Evening0.66 ± 1.260.85 ± 0.83
W8 Change: TA- Morning-0.32 ± 1.000.06 ± 0.84
W8 Change: TA- Noon-0.60 ± 1.130.15 ± 0.74
W8 Change: TA- Evening-0.55 ± 1.080.03 ± 0.76
Baseline: DIS- Morning1.41 ± 1.691.62 ± 1.68
Baseline: DIS- Noon1.55 ± 1.861.62 ± 1.74
Baseline: DIS- Evening1.47 ± 1.861.75 ± 1.73
W8 Change: DIS- Morning-0.51 ± 1.800.38 ± 1.75
W8 Change: DIS- Noon-1.06 ± 1.940.49 ± 1.52
W8 Change: DIS- Evening-0.87 ± 1.710.07 ± 1.54
Baseline: AR- Morning1.14 ± 1.651.40 ± 1.56
Baseline: AR- Noon1.25 ± 1.661.45 ± 1.59
Baseline: AR- Evening1.19 ± 1.811.58 ± 1.67
W8 Change: AR- Morning-0.38 ± 1.580.39 ± 1.60
W8 Change: AR- Noon-0.87 ± 1.700.40 ± 1.18
W8 Change: AR- Evening-0.71 ± 1.53-0.00 ± 1.45
Baseline: ME- Morning0.97 ± 1.321.15 ± 1.11
Baseline: ME- Noon0.98 ± 1.291.09 ± 1.19
Baseline: ME- Evening0.94 ± 1.451.18 ± 1.18
W8 Change: ME- Morning-0.47 ± 1.420.20 ± 1.19
W8 Change: ME- Noon-0.82 ± 1.480.28 ± 1.01
W8 Change: ME- Evening-0.72 ± 1.410.06 ± 1.06
Baseline: MS- Morning0.21 ± 1.080.38 ± 1.01
Baseline: MS- Noon0.25 ± 1.120.32 ± 0.95
Baseline: MS- Evening0.22 ± 1.210.35 ± 1.05
W8 Change: MS- Morning-0.22 ± 1.29-0.04 ± 1.07
W8 Change: MS- Noon-0.39 ± 1.37-0.12 ± 0.94
W8 Change: MS- Evening-0.38 ± 1.31-0.19 ± 1.09
Statistical analysis
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value is for Time Active overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Time Active was tested at rank 8.) · Mean difference (final values): 0.69 · 95% CI 0.52 to 0.87Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value is for Distance overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Distance was tested at rank 5.) · Mean difference (final values): 1.27 · 95% CI 0.98 to 1.57Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value is for Area overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Area was tested at rank 6.) · Mean difference (final values): 1.08 · 95% CI 0.81 to 1.35Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value is for Microevents overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Microevents was tested at rank 3.) · Mean difference (final values): 1.00 · 95% CI 0.78 to 1.22Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value is for Motion Simplicity overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Motion Simplicity was tested at rank 9.) · Mean difference (final values): 0.38 · 95% CI 0.18 to 0.58Positive values for the mean difference are in favor of the atomoxetine arm.
SecondaryChange From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8

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.

Time frame:
Baseline, 8 weeks
Reported as:
Mean · units on a scale
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
units on a scaleAtomoxetinePlacebo
Baseline to Visit 7 (Week 8)-17.19 ± 15.63-4.76 ± 11.51
Baseline to LOCF-15.78 ± 15.19-4.21 ± 10.89
Statistical analysis
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value for ADHD-RS Total Score) · Mean difference (final values): 11.60 · 95% CI 8.20 to 14.99Positive values for the mean difference are in favor of the atomoxetine arm.
SecondaryChange From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8

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).

Time frame:
Baseline, 8 weeks
Reported as:
Mean · units on a scale
Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8
units on a scaleAtomoxetinePlacebo
Baseline to Visit 7 (Week 8)-1.78 ± 1.61-0.63 ± 1.11
Baseline to LOCF-1.52 ± 1.63-0.40 ± 1.17
Statistical analysis
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value for CGI-S ADHD score) · Mean difference (final values): 1.11 · 95% CI 0.76 to 1.46Positive values for the mean difference are in favor of the atomoxetine arm.
SecondaryChange From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8

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).

Time frame:
Baseline, 8 weeks
Reported as:
Mean · units on a scale
Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8
units on a scaleAtomoxetinePlacebo
Total Score: Baseline to Visit 7 (Week 8)-10.72 ± 10.21-5.10 ± 6.83
Total Score: Baseline to LOCF-9.59 ± 9.98-3.90 ± 7.83
Evening Subscore: Baseline to Visit 7 (Week 8)-6.91 ± 6.38-3.57 ± 4.36
Evening Subscore: Baseline to LOCF-6.30 ± 6.21-3.03 ± 5.18
Morning Subscore: Baseline to Visit 7 (Week 8)-2.81 ± 3.04-1.16 ± 2.74
Morning Subscore: Baseline to LOCF-2.46 ± 3.00-0.65 ± 2.94
Item 11 Subscore: Baseline to Visit 7 (Week 8)-1.00 ± 1.60-0.37 ± 1.00
Item 11 Subscore: Baseline to LOCF-0.83 ± 1.60-0.23 ± 1.05
Statistical analysis
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value for Total Score) · Mean difference (final values): 5.74 · 95% CI 3.55 to 7.92Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = 0.001 (P-value for Evening subscore) · Mean difference (final values): 3.96 · 95% CI 2.49 to 5.44Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.002 (P-value for Morning subscore) · Mean difference (final values): 1.18 · 95% CI 0.42 to 1.93Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value for Item 11 (difficulty falling asleep).) · Mean difference (final values): 0.62 · 95% CI 0.31 to 0.93Positive values for the mean difference are in favor of the atomoxetine arm.
PrimaryChange 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

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.

Time frame:
Baseline, 8 weeks
Reported as:
Mean · Q-scores
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
Q-scoresAtomoxetinePlacebo
Baseline: RTV-Morning2.93 ± 2.412.49 ± 1.62
Baseline: RTV-Noon2.95 ± 2.112.48 ± 1.92
Baseline: RTV-Evening2.63 ± 2.492.19 ± 2.00
W8: RTV-Morning-0.89 ± 2.29-0.09 ± 1.78
W8: RTV-Noon-1.07 ± 1.920.00 ± 1.70
W8: RTV-Evening-0.90 ± 1.98-0.00 ± 1.88
Baseline: OR- Morning1.12 ± 1.241.13 ± 1.19
Baseline: OR- Noon1.31 ± 1.321.30 ± 1.32
Baseline: OR- Evening1.22 ± 1.431.28 ± 1.34
W8: OR- Morning0.01 ± 1.830.54 ± 1.14
W8: OR- Noon0.03 ± 1.450.53 ± 1.17
W8: OR- Evening-0.04 ± 1.500.52 ± 1.20
Baseline: mRT- Morning2.42 ± 2.031.92 ± 1.53
Baseline: mRT- Noon2.40 ± 1.782.02 ± 1.49
Baseline: mRT- Evening2.23 ± 1.771.86 ± 1.49
W8: mRT- Morning-0.18 ± 1.840.35 ± 1.28
W8: mRT- Noon-0.35 ± 1.530.12 ± 1.42
W8: mRT- Evening-0.13 ± 1.400.48 ± 1.37
Baseline: nVRT-Morning1.00 ± 1.600.93 ± 1.28
Baseline: nVRT-Noon1.06 ± 1.480.82 ± 1.26
Baseline: nVRT-Evening0.92 ± 1.810.68 ± 1.31
W8: nVRT-Morning-0.59 ± 1.58-0.36 ± 1.15
W8: nVRT-Noon-0.65 ± 1.48-0.09 ± 0.97
W8: nVRT-Evening-0.65 ± 1.75-0.33 ± 1.19
Statistical analysis
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value is for Reaction Time Variation overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Reaction time variation was tested at rank 1.) · Mean difference (final values): 1.01 · 95% CI 0.66 to 1.35Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value is for Omission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Omission error was tested at rank 7.) · Mean difference (final values): 0.70 · 95% CI 0.46 to 0.93Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value is for Mean Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Mean reaction time was tested at rank 2.) · Mean difference (final values): 0.41 · 95% CI 0.17 to 0.65Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value is for Normalized Variation of Reaction Time overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Normalized Variation of Reaction Time was tested at rank 10.) · Mean difference (final values): 0.50 · 95% CI 0.26 to 0.73Positive values for the mean difference are in favor of the atomoxetine arm.
PrimaryChange From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8

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.

Time frame:
Baseline, 8 weeks
Reported as:
Mean · Q-scores
Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8
Q-scoresAtomoxetinePlacebo
Baseline: CE- Morning-0.68 ± 1.34-0.89 ± 1.03
Baseline: CE- Noon-0.65 ± 1.29-0.85 ± 0.94
Baseline: CE- Evening-0.80 ± 1.23-0.87 ± 1.06
W8: CE- Morning-0.88 ± 1.33-0.32 ± 0.90
W8: CE- Noon-0.94 ± 1.33-0.44 ± 0.82
W8: CE- Evening-0.76 ± 1.31-0.49 ± 0.92
Baseline: AR- Morning0.41 ± 1.150.15 ± 0.88
Baseline: AR- Noon0.28 ± 1.060.12 ± 0.85
Baseline: AR- Evening0.32 ± 1.160.08 ± 0.85
W8: AR- Morning-0.50 ± 0.98-0.34 ± 0.84
W8: AR-Noon-0.54 ± 0.87-0.31 ± 0.84
W8: AR- Evening-0.52 ± 0.83-0.28 ± 0.78
Statistical analysis
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value is for Commission Error overall for morning, noon and evening. Primary tests were performed hierarchically to adjust for multiplicity. Commission Error was tested at rank 4.) · Mean difference (final values): 0.50 · 95% CI 0.31 to 0.68Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = 0.022 (P-value is for Anticipatory Response overall for morning, noon and evening. Anticipatory Response was not tested in the primary analysis but is a secondary endpoint.) · Mean difference (final values): 0.17 · 95% CI 0.02 to 0.31Positive values for the mean difference are in favor of the atomoxetine arm.
PrimaryChange From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8

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.

Time frame:
Baseline, 8 weeks
Reported as:
Mean · Q-scores
Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8
Q-scoresAtomoxetinePlacebo
Baseline: ER- Morning0.37 ± 1.560.30 ± 1.15
Baseline: ER- Noon0.52 ± 1.460.41 ± 1.24
Baseline: ER- Evening0.37 ± 1.580.41 ± 1.24
W8: ER- Morning-0.41 ± 2.060.35 ± 1.10
W8: ER- Noon-0.44 ± 1.700.32 ± 1.06
W8: ER- Evening-0.43 ± 1.800.28 ± 1.10
Baseline: MR- Morning-0.04 ± 1.25-0.26 ± 0.84
Baseline: MR- Noon0.01 ± 1.15-0.30 ± 0.95
Baseline: MR- Evening0.03 ± 1.25-0.34 ± 0.89
W8: MR- Morning-0.23 ± 1.15-0.24 ± 0.78
W8: MR- Noon-0.45 ± 0.97-0.16 ± 0.83
W8: MR- Evening-0.35 ± 1.30-0.16 ± 0.77
Statistical analysis
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = <0.001 (P-value is for Error Rate overall for morning, noon and evening. Error Rate was not tested in the primary analysis but is a secondary endpoint.) · Mean difference (final values): 0.94 · 95% CI 0.69 to 1.18Positive values for the mean difference are in favor of the atomoxetine arm.
  • Atomoxetine vs Placebo · Mixed Models Analysis · p = 0.178 (P-value is for Multi Response overall for morning, noon and evening. Multi Response was not tested in the primary analysis but is a secondary endpoint.) · Mean difference (final values): 0.12 · 95% CI 0.05 to 0.28Positive values for the mean difference are in favor of the atomoxetine arm.

Adverse events

Non-serious events are listed at a 4% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Atomoxetine—0/63 (0%)32/63 (50.8%)
Placebo—0/62 (0%)27/62 (43.5%)
Most frequent other events
Showing 10 of 14
Most frequent other events
EventAtomoxetinePlacebo
Abdominal painGastrointestinal disorders7/632/62
NauseaGastrointestinal disorders6/632/62
HeadacheNervous system disorders3/635/62
AggressionPsychiatric disorders0/634/62
FatigueGeneral disorders4/631/62
Upper respiratory tract infectionInfections and infestations4/630/62
Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders4/630/62
Abdominal pain upperGastrointestinal disorders2/633/62
InfluenzaInfections and infestations0/633/62
Respiratory tract infectionInfections and infestations1/633/62

Baseline characteristics

Age Continuous
Age Continuous(years)AtomoxetinePlaceboTotal
Mean9.1 ± 1.938.9 ± 1.649.0 ± 1.79
Sex: Female, Male
Sex: Female, Male(Participants)AtomoxetinePlaceboTotal
Female161228
Male475097
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)AtomoxetinePlaceboTotal
Caucasian6262124
African101
Region of Enrollment
Region of Enrollment(participants)AtomoxetinePlaceboTotal
Germany6362125
Diagnosis
Diagnosis(participants)AtomoxetinePlaceboTotal
ADHD-Combined Type404888
ADHD-Predominantly Inattentive Type171128
ADHD- Predominantly Hyperactive-Impulsive Type639
Number of Participants with Family History of ADHD
Number of Participants with Family History of ADHD(participants)AtomoxetinePlaceboTotal
At least one known relative with ADHD363571
None or missing272754
Number of Participants with Prior Therapy For Attention-Deficit/Hyperactive Disorder (ADHD)
Number of Participants with Prior Therapy For Attention-Deficit/Hyperactive Disorder (ADHD)(participants)AtomoxetinePlaceboTotal
Previous treatment for ADHD262753
None or missing373572
Number of Participants with Psychiatric Comorbidities
Number of Participants with Psychiatric Comorbidities(participants)AtomoxetinePlaceboTotal
At least one psychiatric comorbidity252550
None or missing383775

6 further baseline measures are reported on the registry.

08

Study locations

16 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Berlin, 12589, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Datteln, 45711, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Dorsten, 46282, Germany
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    Dusseldorf, 40215, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Eberswalde, 16225, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Freiburg, 79104, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Fulda, 36037, Germany
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    Giessen, 35390, Germany
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    Hagen, 58093, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Hannover, 30449, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Kehl, 77694, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Köln, D-50931, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Mannheim, 68159, Germany
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    Munchen, 80639, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Solingen, 42719, Germany
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    Wolfenbüttel, 38300, Germany
09

References and documents

Publications

  • Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14. PubMed 25019647 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00546910
Lead sponsor
Eli Lilly and Company
First posted
Oct 19, 2007
Start date
Oct 2007
Primary completion
May 2009
Completion
May 2009
Results posted
Jun 23, 2010
Last update
Aug 10, 2010

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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