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CompletedNCT00447278ADHD LIFEUpdated Apr 27, 2010Results posted

A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents

A Phase 3 interventional study of Atomoxetine and Other standard therapy for ADHD in Attention Deficit Hyperactivity Disorder, sponsored by Eli Lilly and Company. Completed at 35 sites in 9 countries. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2010-04-27.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
399
Allocation
Randomized
Ages
6 Years to 16 Years
Sex
All
01

Study summary

The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.

02

Conditions studied

  • Attention Deficit Hyperactivity Disorder
03

In context

Attention Deficit Disorder with Hyperactivity

1,547 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.

This study's enrollment of 399 is above the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Browse Eli Lilly and Company studies →

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

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Inclusion criteria:

    • 6 to 16 years old
    • Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (SADS PL)
    • Pharmacological naïve
    • Normal intelligence as assessed by investigator
    • Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.

Exclusion Criteria:

  • Exclusion criteria

    • History of bipolar disorder, any history of psychosis or autism spectrum disorder
    • History of any seizure disorder
    • Significant prior or current medical conditions
    • History of alcohol or drug abuse within the past 3 months
    • Patients who are taking concurrently any of the excluded medications in the study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
399 participants (actual)

Study arms

  • Experimental
    Atomoxetine

    0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension

    Drug: Atomoxetine

  • Active comparator
    OEST

    Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

    Drug: Other standard therapy for ADHD

Interventions

  • DrugAtomoxetine

    0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension

    Also known as: LY139603, Strattera

  • DrugOther standard therapy for ADHD

    Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

06

What researchers measure

Primary outcomes

  1. Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain

    CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain

    CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.

    Time frame: Baseline, 4 months, 12 months

  2. Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)

    CHIP-CE PRF: parent rated assessment of a child's health status and level of functioning. Domains: Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.

    Time frame: Baseline, 4 months, 6 months, 12 months

  3. Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)

    The 50-item WFIRS-P rates impairment in 6 domains of functioning: home, school, self-concept, social, activities of daily living, and risk taking. Each item is rated by the parent on a 4-point Likert scale from 0 to 3 (0="never or not at all", 1="sometimes or somewhat", 2="often or much", 3="very often or very much"). Average of non-missing values were calculated for each domain as well as the Total, which combined all 6 domains; therefore each scale including total has a range of 0 (best) to 3 (worst).

    Time frame: Baseline, 4 months, 6 months, 12 months

  4. Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)

    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. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subcale scores ranging from 0 to 27. Higher scores are indicative of more severe symptoms.

    Time frame: Baseline, 4 months, 6 months, 12 months

  5. Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)

    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, 4 months, 6 months, 12 months

  6. Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)

    CHIP-CE CRF: child rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.

    Time frame: Baseline, 4 months, 6 months, 12 months

  7. Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)

    CHIP-AE CRF: adolescent rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.

    Time frame: Baseline, 4 months, 6 months, 12 months

  8. Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores

    Pearson correlation coefficients were calculated on each domain at baseline, Month 6 and Change to Month 6 between parent-rated CHIP and pooled patient-rated (child and adolescent) CHIP.

    Time frame: Baseline, 6 months

07

Results

Posted Apr 20, 2010

Participant flow

Period II (6 Month Open-Label)
Participant flow — Period II (6 Month Open-Label)
MilestoneAtomoxetineOEST
Started199200
Received at least one dose of study drug199199
Completed157171
Not completed4229
Withdrew: Adverse event73
Withdrew: Lost to follow-up04
Withdrew: Protocol violation107
Withdrew: Withdrawal by subject13
Withdrew: Physician decision41
Withdrew: Lack of efficacy111
Withdrew: Parent/guardian decision910
Period III (Optional 6 Month Extension)
Participant flow — Period III (Optional 6 Month Extension)
MilestoneAtomoxetineOEST
Started139155
Completed109140
Not completed3015
Withdrew: Adverse event22
Withdrew: Lost to follow-up22
Withdrew: Protocol violation61
Withdrew: Withdrawal by subject41
Withdrew: Physician decision11
Withdrew: Lack of efficacy40
Withdrew: Parent/guardian decision118

Outcome measures

PrimaryChange From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain

CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.

Time frame:
Baseline, 6 months
Reported as:
Mean · T-Scores of units on a scale
Change From Baseline to 6 Month Endpoint in Child Health and Illness Profile - Child Edition, Parent Report Form (CHIP-CE PRF), Achievement Domain
T-Scores of units on a scaleAtomoxetineOEST
Baseline (n=198, n=199)28.0 ± 12.0428.3 ± 12.28
Change from Baseline at 6 Months (n=150, n=166)8.4 ± 10.1512.4 ± 11.37
Change from Baseline: 6 Month LOCF (n=192,n=195)7.3 ± 10.7111.7 ± 11.24
Statistical analysis
  • Atomoxetine vs OEST · Mixed Models Analysis · p = <0.001 (P-value for Change from Baseline at 6 Months. P-value is not adjusted and the threshold is 0.05.) · Least squares mean difference: -4.36 · 95% CI -6.47 to -2.25Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = <0.001 (P-value for Change from Baseline: 6 Month LOCF.) · Least squares mean difference: -4.60 · 95% CI -6.56 to -2.63Least Squares Mean Difference = Atomoxetine minus OEST.
SecondaryChange From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain

CHIP-CE PRF: parent rated assessment of a child's health status/level of functioning. The achievement domain describes developmentally appropriate role functioning in school and with peers. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.

Time frame:
Baseline, 4 months, 12 months
Reported as:
Mean · T-Scores of units on a scale
Change From Baseline to 4 Month and 12 Month Endpoints in CHIP-CE PRF, Achievement Domain
T-Scores of units on a scaleAtomoxetineOEST
Change from Baseline: 4 Month LOCF (n=192, n=195)7.8 ± 10.8410.7 ± 11.32
Month 6 Baseline (M6B) (n=132, n=148)37.7 ± 11.7541.2 ± 12.28
Change from M6B at 12 Months (n=104, n=128)1.2 ± 10.60-0.9 ± 9.51
Statistical analysis
  • Atomoxetine vs OEST · ANCOVA · p = 0.002 (P-value for Change from Baseline: 4 Month LOCF.) · Least squares mean difference: -3.10 · 95% CI -5.08 to -1.13Least Squares Mean Difference = Atomoxetine minus OEST.
SecondaryChange From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)

CHIP-CE PRF: parent rated assessment of a child's health status and level of functioning. Domains: Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.

Time frame:
Baseline, 4 months, 6 months, 12 months
Reported as:
Mean · T-Scores of units on a scale
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE PRF Domain Scores (Satisfaction, Comfort, Resilience and Risk Avoidance)
T-Scores of units on a scaleAtomoxetineOEST
Comfort Baseline (n=198, n=198)43.4 ± 11.5843.0 ± 11.27
Comfort Change at 4 Month LOCF (n=191, n=194)1.9 ± 10.605.2 ± 11.22
Comfort Change at 6 Month LOCF (n=191, n=194)2.3 ± 11.144.7 ± 11.64
Comfort Month 6 Baseline (n=137, n=153)46.5 ± 10.9847.7 ± 9.78
Comfort Change at 12 Months (n=109, n=134)0.2 ± 10.38-0.5 ± 10.28
Resilience Baseline (n=199, n=197)37.8 ± 14.5938.9 ± 12.63
Resilience Change at 4 Month LOCF (n=193, n=193)4.9 ± 12.193.8 ± 13.38
Resilience Change at 6 Month LOCF (n=193, n=193)5.0 ± 12.865.5 ± 12.99
Resilience Month 6 Baseline (n=136, n=152)44.3 ± 14.7845.3 ± 14.08
Resilience Change at 12 Months (n=109, n=133)-1.6 ± 12.38-0.3 ± 11.98
Risk Avoidance Baseline (n=198, n=198)29.7 ± 20.1831.2 ± 20.14
Risk Avoidance Change: 4 Month LOCF (n=192, n=194)9.0 ± 13.639.3 ± 14.20
Risk Avoidance Change: 6 Month LOCF (n=192, n=194)8.0 ± 12.909.6 ± 15.16
Risk Avoidance Month 6 Baseline (n=132, n=149)40.1 ± 16.4541.1 ± 16.23
Risk Avoidance Change at 12 Months (n=104, n=130)1.0 ± 10.982.2 ± 10.25
Satisfaction Baseline (n=199, n=198)33.4 ± 16.1632.8 ± 16.29
Satisfaction Change at 4 Month LOCF (n=193, n=194)3.1 ± 13.536.9 ± 16.18
Satisfaction Change at 6 Month LOCF (n=193, n=194)4.1 ± 13.517.2 ± 15.94
Satisfaction Month 6 Baseline (n=138, n=153)39.6 ± 15.7340.7 ± 16.17
Satisfaction Change at 12 Months (n=110, n=134)-0.9 ± 14.141.0 ± 10.96
Statistical analysis
  • Atomoxetine vs OEST · ANCOVA · p = 0.002 (P-value for Comfort Change at 4 Month LOCF.) · Least squares mean difference: -3.04 · 95% CI -4.92 to -1.15Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.031 (P-value for Comfort Change at 6 Month LOCF.) · Least squares mean difference: -2.10 · 95% CI -4.01 to -0.20Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.629 (P-value for Resilience Change at 4 Month LOCF.) · Least squares mean difference: 0.55 · 95% CI -1.68 to 2.77Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.421 (P-value for Resilience Change at 6 Month LOCF.) · Least squares mean difference: -0.96 · 95% CI -3.30 to 1.38Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.388 (P-value for Risk Avoidance Change: 4 Month LOCF.) · Least squares mean difference: -1.05 · 95% CI -3.44 to 1.34Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.059 (P-value for Risk Avoidance Change: 6 Month LOCF.) · Least squares mean difference: -2.29 · 95% CI -4.66 to 0.09Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.006 (P-value for Satisfaction Change at 4 Month LOCF.) · Least squares mean difference: -3.56 · 95% CI -6.09 to -1.04Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.027 (P-value for Satisfaction Change at 6 Month LOCF.) · Least squares mean difference: -2.91 · 95% CI -5.49 to -0.33Least Squares Mean Difference = Atomoxetine minus OEST.
SecondaryChange From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)

The 50-item WFIRS-P rates impairment in 6 domains of functioning: home, school, self-concept, social, activities of daily living, and risk taking. Each item is rated by the parent on a 4-point Likert scale from 0 to 3 (0="never or not at all", 1="sometimes or somewhat", 2="often or much", 3="very often or very much"). Average of non-missing values were calculated for each domain as well as the Total, which combined all 6 domains; therefore each scale including total has a range of 0 (best) to 3 (worst).

Time frame:
Baseline, 4 months, 6 months, 12 months
Reported as:
Mean · units on a scale
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P)
units on a scaleAtomoxetineOEST
Total Baseline (n=192, n=194)1.02 ± 0.4750.96 ± 0.453
Total Change at 4 Months LOCF (n=187, n=190)-0.30 ± 0.328-0.35 ± 0.357
Total Change at 6 Month LOCF (n=187, n=190)-0.30 ± 0.333-0.36 ± 0.363
Total 6 Month Baseline (n=134, n=150)0.62 ± 0.3560.59 ± 0.344
Total Change at 12 Months (n=103, n=126)-0.01 ± 0.247-0.02 ± 0.252
Home Baseline (n=196, n=199)1.28 ± 0.7771.19 ± 0.728
Home Change at 4 Month LOCF (n=190, n=195)-0.40 ± 0.608-0.45 ± 0.591
Home Change at 6 Month LOCF (n=190, n=195)-0.40 ± 0.590-0.44 ± 0.599
Home 6 Month Baseline (n=139, n=152)0.74 ± 0.5920.72 ± 0.557
Home Change at 12 Months (n=109, n=131)0.01 ± 0.414-0.04 ± 0.440
Daily Living Baseline (n=197, n=196)1.06 ± 0.5591.07 ± 0.519
Daily Living Change at 4 Month LOCF (n=191, n=192)-0.20 ± 0.477-0.25 ± 0.427
Daily Living Change at 6 Month LOCF (n=191, n=192)-0.20 ± 0.467-0.27 ± 0.427
Daily Living 6 Month Baseline (n=139, n=152)0.82 ± 0.4450.81 ± 0.429
Daily Living Change at 12 Months (n=108, n=131)-0.04 ± 0.334-0.03 ± 0.365
Risk Taking Baseline (n=198, n=199)0.51 ± 0.4240.45 ± 0.383
Risk Taking Change at 4 Month LOCF (n=192, n=195)-0.16 ± 0.277-0.17 ± 0.272
Risk Taking Change at 6 Month LOCF (n=192, n=195)-0.17 ± 0.285-0.18 ± 0.269
Risk Taking 6 Month Baseline (n=139, n=151)0.29 ± 0.3120.25 ± 0.302
Risk Taking Change at 12 Months (n=109, n=130)-0.01 ± 0.199-0.02 ± 0.207
School Baseline (n=198, n=199)1.24 ± 0.5921.18 ± 0.617
School Change at 4 Month LOCF (n=192, n=195)-0.49 ± 0.504-0.57 ± 0.563
School Change at 6 Month LOCF (n=192, n=195)-0.49 ± 0.523-0.60 ± 0.565
School 6 Month Baseline (n=138, n=152)0.62 ± 0.4590.53 ± 0.444
School Change at 12 Months (n=107, n=132)-0.03 ± 0.455-0.03 ± 0.389
Self-Concept Baseline (n=198, n=198)0.94 ± 0.7870.85 ± 0.726
Self-Concept Change at 4 Month LOCF (n=192, n=194)-0.25 ± 0.738-0.31 ± 0.723
Self-Concept Change at 6 Month LOCF (n=192, n=194)-0.27 ± 0.758-0.32 ± 0.728
Self-Concept 6 Month Baseline (n=137, n=132)0.55 ± 0.5740.50 ± 0.538
Self-Concept Change at 12 Months (n=107, n=131)0.02 ± 0.6150.02 ± 0.529
Social Baseline (n=198, n=198)1.02 ± 0.6610.97 ± 0.602
Social Change at 4 Month LOCF (n=192, n=194)-0.26 ± 0.491-0.32 ± 0.513
Social Change at 6 Month LOCF (n=192, n=194)-0.28 ± 0.536-0.30 ± 0.521
Social 6 Month Baseline (n=139, n=152)0.64 ± 0.4910.67 ± 0.499
Social Change at 12 Months (n=109, n=132)-0.02 ± 0.405-0.03 ± 0.371
Statistical analysis
  • Atomoxetine vs OEST · ANCOVA · p = 0.015 (P-value for Total Change at 4 Month LOCF.) · Least squares mean difference: 0.073 · 95% CI 0.014 to 0.131Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.004 (P-value for Total Change at 6 Month LOCF.) · Least squares mean difference: 0.085 · 95% CI 0.027 to 0.143Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.063 (P-value for Home Change at 4 Month LOCF.) · Least squares mean difference: 0.094 · 95% CI -0.005 to 0.192Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.131 (P-value for Home Change at 6 Month LOCF.) · Least squares mean difference: 0.075 · 95% CI -0.022 to 0.172Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.156 (P-value for Daily Living Change at 4 Month LOCF.) · Least squares mean difference: 0.052 · 95% CI -0.020 to 0.124Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.046 (P-value for Daily Living Change at 6 Month LOCF.) · Least squares mean difference: 0.072 · 95% CI 0.001 to 0.143Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.068 (P-value for Risk Taking Change at 4 Month LOCF.) · Least squares mean difference: 0.040 · 95% CI -0.003 to 0.084Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.212 (P-value for Risk Taking Change at 6 Month LOCF.) · Least squares mean difference: 0.028 · 95% CI -0.016 to 0.073Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.006 (P-value for School Change at 4 Month LOCF.) · Least squares mean difference: 0.121 · 95% CI 0.034 to 0.208Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = <0.001 (P-value for School Change at 6 Month LOCF.) · Least squares mean difference: 0.150 · 95% CI 0.064 to 0.236Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.034 (P-value for Self-Concept Change at 4 Month LOCF.) · Least squares mean difference: 0.125 · 95% CI 0.009 to 0.240Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.040 (P-value for Self-Concept Change at 6 Month LOCF.) · Least squares mean difference: 0.119 · 95% CI 0.005 to 0.233Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.042 (p-value for Social Change at 4 Month LOCF.) · Least squares mean difference: 0.085 · 95% CI 0.003 to 0.166Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.271 (P-value for Social Change at 6 Month LOCF.) · Least squares mean difference: 0.048 · 95% CI -0.038 to 0.134Least Squares Mean Difference = Atomoxetine minus OEST.
SecondaryChange From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)

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. Inattention and Hyperactivity-Impulsivity subscales consisted of 9 items each, for total subcale scores ranging from 0 to 27. Higher scores are indicative of more severe symptoms.

Time frame:
Baseline, 4 months, 6 months, 12 months
Reported as:
Mean · units on a scale
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Attention-Deficit/Hyperactivity Disorder Rating Scale - Parent Version: Investigator Adminitered and Scored (ADHD-RS-IV Parent:Inv)
units on a scaleAtomoxetineOEST
Total Baseline (n=199, n=198)40.87 ± 8.67440.35 ± 8.818
Total Change at 4 Month LOCF (n=193, n=194)-18.1 ± 11.726-20.1 ± 11.562
Total Change at 6 Month LOCF (n=193, n=194)-17.6 ± 11.688-20.3 ± 11.397
Total 6 Month Baseline (n=137, n=154)20.84 ± 10.92318.62 ± 10.255
Total Change at 12 Months (n=108, n=138)-2.35 ± 9.393-2.71 ± 8.998
Inattention Baseline (n=199, n=198)21.91 ± 4.13821.55 ± 4.373
Inattention Change at 4 Month LOCF (n=193, n=194)-9.58 ± 6.510-11.1 ± 6.150
Inattention Change at 6 Month LOCF (n=193, n=194)-9.15 ± 6.544-11.2 ± 6.339
Inattention 6 Month Baseline (n=137, n=154)11.52 ± 5.9369.51 ± 5.510
Inattention Change at 12 Months (n=108, n=139)-1.17 ± 5.359-1.13 ± 5.273
Hyperactivity Baseline (n=199, n=198)18.97 ± 6.08218.80 ± 6.252
Hyperactivity Change at 4 Month LOCF (n=193,n=194)-8.54 ± 6.166-8.97 ± 6.572
Hyperactivity Change at 6 Month LOCF (n=193,n=194)-8.42 ± 6.189-9.13 ± 6.255
Hyperactivity 6 Month Baseline (n=138, n=154)9.36 ± 5.9729.11 ± 5.770
Hyperactivity Change at 12 Months (n=109, n=138)-1.24 ± 4.965-1.63 ± 4.644
Statistical analysis
  • Atomoxetine vs OEST · ANCOVA · p = 0.034 (P-value for Total Change at 4 Month LOCF.) · Least squares mean difference: 2.307 · 95% CI 0.173 to 4.440Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.005 (P-value for Total Change at 6 Month LOCF.) · Least squares mean difference: 3.072 · 95% CI 0.942 to 5.202Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.004 (P-value for Inattention Change at 4 Month LOCF.) · Least squares mean difference: 1.721 · 95% CI 0.544 to 2.899Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = <0.001 (P-value for Inattention Change at 6 Month LOCF.) · Least squares mean difference: 2.269 · 95% CI 1.086 to 3.453Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.298 (P-value for Hyperactivity Change at 4 Month LOCF.) · Least squares mean difference: 0.580 · 95% CI -0.515 to 1.676Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.119 (P-value for Hyperactivity Change at 6 Month LOCF.) · Least squares mean difference: 0.865 · 95% CI -0.225 to 1.956Least Squares Mean Difference = Atomoxetine minus OEST.
SecondaryChange From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)

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, 4 months, 6 months, 12 months
Reported as:
Mean · units on a scale
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in Clinical Global Impression Attention-Deficit/Hyperactivity Disorder - Severity (CGI-ADHD-S)
units on a scaleAtomoxetineOEST
Baseline (n=199, n=199)5.54 ± 0.8575.45 ± 0.903
Change at 4 Month LOCF (n=199, n=199)-1.88 ± 1.252-1.94 ± 1.228
Change at 6 Month LOCF (n=199, n=199)-1.94 ± 1.351-2.06 ± 1.323
6 Month Baseline (n=138, n=153)3.21 ± 1.1043.17 ± 1.229
Change at 12 Months (n=109, n=137)-0.28 ± 1.037-0.57 ± 0.953
Statistical analysis
  • Atomoxetine vs OEST · ANCOVA · p = 0.366 (P-value for Change at 4 Month LOCF.) · Least squares mean difference: 0.104 · 95% CI -0.122 to 0.329Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.165 (P-value for Change at 6 Month LOCF.) · Least squares mean difference: 0.169 · 95% CI -0.070 to 0.407Least Squares Mean Difference = Atomoxetine minus OEST.
SecondaryChange From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)

CHIP-CE CRF: child rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.

Time frame:
Baseline, 4 months, 6 months, 12 months
Reported as:
Mean · T-Scores of units on a scale
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-CE CRF for Children (6-11 Years)
T-Scores of units on a scaleAtomoxetineOEST
Achievement Baseline (n=157, n=155)35.8 ± 14.1536.5 ± 13.03
Achievement Change at 4 Month LOCF (n=139, n=135)4.6 ± 12.297.0 ± 12.38
Achievement Change at 6 Month LOCF (n=145, n=142)5.1 ± 12.828.8 ± 12.19
Achievement 6 Month Baseline (n=108, n=117)43.8 ± 13.6646.3 ± 12.50
Achievement Change at 12 Months (n=87, n=105)-0.5 ± 9.71-0.1 ± 11.19
Comfort Baseline (n=159, n=155)49.1 ± 10.3948.2 ± 9.20
Comfort Change at 4 Month LOCF (n=146, n=140)2.8 ± 9.255.2 ± 8.74
Comfort Change at 6 Month LOCF (n=147, n=143)3.1 ± 9.726.3 ± 9.14
Comfort 6 Month Baseline (n=108, n=122)52.2 ± 8.4354.0 ± 8.15
Comfort Change at 12 Months (n=87, n=109)-0.0 ± 7.141.4 ± 7.07
Resilience Baseline (n=159, n=155)46.1 ± 12.1346.0 ± 11.12
Resilience Change at 4 Month LOCF (n=146, n=140)1.9 ± 10.521.3 ± 11.25
Resilience Change at 6 Month LOCF (n=147, n=143)2.9 ± 11.082.7 ± 12.08
Resilience 6 Month Baseline (n=108, n=122)50.0 ± 10.3348.7 ± 11.35
Resilience Change at 12 Months (n=87, n=109)-1.8 ± 8.97-1.0 ± 9.14
Risk Avoidance Baseline (n=158, n=155)44.1 ± 11.8144.3 ± 11.65
Risk Avoidance Change: 4 Month LOCF (n=139, n=135)6.2 ± 11.177.6 ± 10.02
Risk Avoidance Change: 6 Month LOCF (n=145, n=142)6.0 ± 10.898.9 ± 10.48
Risk Avoidance 6 Month Baseline (n=108, n=118)51.2 ± 8.6153.3 ± 9.02
Risk Avoidance Change at 12 Months (n=87, n=106)-0.6 ± 8.10-0.4 ± 7.30
Satisfaction Baseline (n=159, n=155)47.1 ± 13.5045.2 ± 12.18
Satisfaction Change at 4 Month LOCF (n=146, n=140)0.3 ± 10.404.1 ± 12.23
Satisfaction Change at 6 Month LOCF (n=147, n=143)0.7 ± 10.724.9 ± 12.17
Satisfaction 6 Month Baseline (n=108, n=121)49.4 ± 11.6650.1 ± 11.07
Satisfaction Change at 12 Months (n=87, n=109)0.4 ± 10.610.5 ± 8.91
Statistical analysis
  • Atomoxetine vs OEST · ANCOVA · p = 0.054 (P-value for Achievement Change at 4 Month LOCF.) · Least squares mean difference: -2.35 · 95% CI -4.74 to 0.04Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.003 (P-value for Achievement Change at 6 Month LOCF.) · Least squares mean difference: -3.71 · 95% CI -6.16 to -1.26Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.033 (P-value for Comfort Change at 4 Month LOCF.) · Least squares mean difference: -1.74 · 95% CI -3.33 to -0.14Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.003 (P-value for Comfort Change at 6 Month LOCF.) · Least squares mean difference: -2.50 · 95% CI -4.12 to -0.88Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.623 (P-value for Resilience Change at 4 Month LOCF.) · Least squares mean difference: 0.50 · 95% CI -1.50 to 2.50Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.880 (P-value for Resilience Change at 6 Month LOCF.) · Least squares mean difference: 0.16 · 95% CI -1.96 to 2.29Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.149 (P-value for Risk Avoidance Change: 4 Month LOCF.) · Least squares mean difference: -1.40 · 95% CI -3.31 to 0.50Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.003 (P-value for Risk Avoidance Change: 6 Month LOCF.) · Least squares mean difference: -2.78 · 95% CI -4.58 to -0.98Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.015 (P-value for Satisfaction Change at 4 Month LOCF.) · Least squares mean difference: -2.62 · 95% CI -4.71 to -0.52Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.004 (P-value for Satisfaction Change at 6 Month LOCF.) · Least squares mean difference: -3.12 · 95% CI -5.26 to -0.98Least Squares Mean Difference = Atomoxetine minus OEST.
SecondaryChange From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)

CHIP-AE CRF: adolescent rated assessment of their health status and level of functioning. Domains: Achievement, Satisfaction, Comfort, Risk Avoidance, Resilience. The majority of items assess frequency of activities or feelings using a 5-point response format (1=never, 5=always). Standard scores (T-scores) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Normative range is 40 to 60. Higher scores indicate better health and lower scores indicate worse health.

Time frame:
Baseline, 4 months, 6 months, 12 months
Reported as:
Mean · T-Scores of units on a scale
Change From Baseline to 4 Month, 6 Month, and 12 Month Endpoints in the CHIP-Adolescent Edition (AE) for Adolescents (>11-17 Years)
T-Scores of units on a scaleAtomoxetineOEST
Achievement Baseline (n=37, n=37)49.1 ± 10.6349.3 ± 9.72
Achievement Change at 4 Month LOCF (n=31, n=32)4.9 ± 11.621.5 ± 8.33
Achievement Change at 6 Month LOCF (n=32, n=35)3.1 ± 11.042.3 ± 7.96
Achievement 6 Month Baseline (n=26, n=30)53.7 ± 9.8952.2 ± 10.91
Achievement Change at 12 Months (n=17, n=24)-1.8 ± 5.46-0.5 ± 8.48
Satisfaction Baseline (n=37, n=38)49.7 ± 8.6849.6 ± 11.62
Satisfaction Change at 4 Month LOCF (n=31, n=34)2.1 ± 7.212.4 ± 6.83
Satisfaction Change at 6 Month LOCF (n=32, n=36)2.8 ± 7.626.3 ± 8.51
Satisfaction 6 Month Baseline (n=26, n=30)51.2 ± 10.5555.4 ± 7.56
Satisfaction Change at 12 Months (n=17, n=25)-2.6 ± 4.79-1.4 ± 6.79
Comfort Baseline (n=37, n=38)53.0 ± 9.1151.6 ± 9.00
Comfort Change at 4 Month LOCF (n=31, n=33)1.4 ± 11.242.6 ± 7.21
Comfort Change at 6 Month LOCF (n=32, n=35)1.3 ± 11.874.7 ± 7.27
Comfort 6 Month Baseline (n=26, n=30)55.1 ± 7.8155.8 ± 6.36
Comfort Change at 12 Months (n=17, n=25)2.3 ± 7.26-0.2 ± 5.06
Risk Avoidance Baseline (n=37, n=37)55.2 ± 8.1054.4 ± 7.95
Risk Avoidance Change: 4 Month LOCF (n=31, n=33)1.3 ± 6.352.0 ± 3.56
Risk Avoidance Change: 6 Month LOCF (n=32, n=35)0.6 ± 6.742.8 ± 3.89
Risk Avoidance 6 Month Baseline (n=26, n=30)57.5 ± 8.4657.6 ± 7.12
Risk Avoidance Change at 12 Months (n=17, n=23)-1.2 ± 4.510.1 ± 2.68
Resilience Baseline (n=35, n=37)45.0 ± 9.3345.4 ± 7.33
Resilience Change at 4 Month LOCF (n=29, n=33)0.8 ± 6.920.3 ± 5.67
Resilience Change at 6 Month LOCF (n=30, n=35)-0.7 ± 6.141.8 ± 7.36
Resilience 6 Month Baseline (n=26, n=30)44.1 ± 7.8947.9 ± 8.25
Resilience Change at 12 Months (n=17, n=24)-1.4 ± 6.25-1.7 ± 7.53
Statistical analysis
  • Atomoxetine vs OEST · ANCOVA · p = 0.263 (P-value for Achievement Change at 4 Month LOCF. Achievement was derived from the academic achievement subdomain only.) · Least squares mean difference: 2.39 · 95% CI -1.83 to 6.60Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.848 (P-value for Achievement Change at 6 Month LOCF. Achievement was derived from the academic achievement subdomain only.) · Least squares mean difference: 0.38 · 95% CI -3.60 to 4.36Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.895 (P-value for Statisfaction Change at 4 Month LOCF.) · Least squares mean difference: -0.19 · 95% CI -3.01 to 2.64Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.038 (P-value for Satisfaction Change at 6 Month LOCF.) · Least squares mean difference: -3.20 · 95% CI -6.22 to -0.19Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.854 (P-value for Comfort Change at 4 Month LOCF.) · Least squares mean difference: -0.30 · 95% CI -3.59 to 2.98Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.161 (P-value for Comfort Change at 6 Month LOCF.) · Least squares mean difference: -2.26 · 95% CI -5.45 to 0.92Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.540 (P-value for Risk Avoidance Change: 4 Month LOCF.) · Least squares mean difference: -0.70 · 95% CI -2.98 to 1.58Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.106 (P-value for Risk Avoidance Change: 6 Month LOCF.) · Least squares mean difference: -1.98 · 95% CI -4.40 to 0.44Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.833 (P-value for Resilience Change at 4 Month LOCF.) · Least squares mean difference: 0.30 · 95% CI -2.49 to 3.08Least Squares Mean Difference = Atomoxetine minus OEST.
  • Atomoxetine vs OEST · ANCOVA · p = 0.110 (P-value for Resilience Change at 6 Month LOCF.) · Least squares mean difference: -2.34 · 95% CI -5.21 to 0.54Least Squares Mean Difference = Atomoxetine minus OEST.
SecondaryCorrelation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores

Pearson correlation coefficients were calculated on each domain at baseline, Month 6 and Change to Month 6 between parent-rated CHIP and pooled patient-rated (child and adolescent) CHIP.

Time frame:
Baseline, 6 months
Reported as:
Number · correlation coefficient
Correlation Between CHIP-CE Parent Rated and Pooled CHIP-CE Child Rated and CHIP AE Adolescent Rated T-Scores
correlation coefficientPearson Correlation Coefficient
Achievement Baseline0.288
Achievement Month 60.329
Achievement Change to Month 60.167
Comfort Baseline0.306
Comfort Month 60.373
Comfort Change to Month 60.286
Resilience Baseline0.271
Resilience Month 60.429
Resilience Change to Month 60.113
Risk Avoidance Baseline0.429
Risk Avoidance Month 60.450
Risk Avoidance Change to Month 60.296
Satisfaction Baseline0.310
Satisfaction Month 60.336
Satisfaction Change to Month 60.133

Adverse events

Collected over Baseline to 6 months (Study Period II). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Atomoxetine—2/199 (1%)150/199 (75.4%)
OEST—2/199 (1%)146/199 (73.4%)
Most frequent serious events
Most frequent serious events
EventAtomoxetineOEST
Otitis mediaInfections and infestations1/1990/199
Pyelonephritis acuteInfections and infestations1/1990/199
ConcussionInjury, poisoning and procedural complications0/1991/199
Juvenile arthritisMusculoskeletal and connective tissue disorders0/1991/199
Most frequent other events
Showing 10 of 16
Most frequent other events
EventAtomoxetineOEST
AnorexiaMetabolism and nutrition disorders40/19950/199
HeadacheNervous system disorders48/19944/199
Abdominal painGastrointestinal disorders29/19922/199
Decreased appetiteMetabolism and nutrition disorders25/19928/199
NauseaGastrointestinal disorders25/19914/199
InsomniaPsychiatric disorders4/19925/199
FatigueGeneral disorders23/1995/199
VomitingGastrointestinal disorders21/19911/199
Abdominal pain upperGastrointestinal disorders18/19913/199
Weight decreasedInvestigations17/1998/199

Baseline characteristics

Age Continuous
Age Continuous(years)AtomoxetineOESTTotal
Mean9.2 ± 2.579.4 ± 2.649.3 ± 2.60
Sex: Female, Male
Sex: Female, Male(Participants)AtomoxetineOESTTotal
Female414182
Male158158316
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)AtomoxetineOESTTotal
African022
Caucasian180181361
East Asian213
Hispanic171532
Region of Enrollment
Region of Enrollment(participants)AtomoxetineOESTTotal
France323264
Mexico111223
Belgium232346
Spain6158119
Ireland325
Turkey232447
Norway101020
United Kingdom161834
Italy202040
Kiddie Schedule for Affective Disorders - Affective Disorder
Kiddie Schedule for Affective Disorders - Affective Disorder(participants)AtomoxetineOESTTotal
0 Affective Disorders189189378
1 Affective Disorder213
Missing Information8917
Kiddie Schedule for Affective Disorders - Anxiety Disorder
Kiddie Schedule for Affective Disorders - Anxiety Disorder(participants)AtomoxetineOESTTotal
0 Anxiety Disorders176173349
1 Anxiety Disorder111829
2 Anxiety Disorders4610
3 Anxiety Disorders202
4 Anxiety Disorders101
Missing Information527
Kiddie Schedule for Affective Disorders - Attention-Deficit/Hyperactivity Disorder (ADHD) Subtypes
Kiddie Schedule for Affective Disorders - Attention-Deficit/Hyperactivity Disorder (ADHD) Subtypes(participants)AtomoxetineOESTTotal
Combined ADHD Subtype156156312
Hyperactive/Impulsive ADHD Subtype4711
Inattentive ADHD Subtype393675
Kiddie Schedule for Affective Disorders - Conduct Disorder
Kiddie Schedule for Affective Disorders - Conduct Disorder(participants)AtomoxetineOESTTotal
Yes (currently have the disorder)131023
Yes, but not present (had disorder in the past)224
No (never had the disorder)184187371

6 further baseline measures are reported on the registry.

08

Study locations

35 sites
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    Brussels, 1200, Belgium
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    Hoboken, 2660, Belgium
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    Leuven, 3000, Belgium
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    Amiens, 80084, France
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    Bordeaux, 33076, France
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    Lyon, 69395, France
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    Montpellier, 34 295, France
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    Paris, 75019, France
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    Toulouse, 31059, France
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    Tours, 37044, France
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    Westside, Galway, Ireland
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    Dublin, Ireland
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    Messina, 98125, Italy
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    Naples, 80131, Italy
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    S.Vito Tagliamento, 37078, Italy
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    San Donà di Piave, 30027, Italy
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    Insurgentes Cuicuilco, 04530, Mexico
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    Mexico City, 06720, Mexico
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    Roma Sur, 06760, Mexico
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    Bergen, N-5021, Norway
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    Fredrikstad, 1606, Norway
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    Alicante, 03114, Spain
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    Barcelona, 08035, Spain
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    Donostia / San Sebastian, 20009, Spain
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    Espluges de Llobregat, 08950, Spain
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    Palma de Mallorca, 07198, Spain
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    Pamplona, 31008, Spain
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    Sabadell, 08208, Spain
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    Valencia, 46010, Spain
  • 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.
    Adana, Turkey (Türkiye)
  • 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.
    Ankara, 06100, Turkey (Türkiye)
  • 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.
    Izmir, 35340, Turkey (Türkiye)
  • 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.
    Basildon, Essex SS15 5NL, United Kingdom
  • 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.
    Wigan, Lancashire WN2 2JA, United Kingdom
  • 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.
    Sheffield, South Yorkshire S10 5DD, United Kingdom
09

References and documents

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2007, a primary completion of Mar 2009 and a completion of Jul 2009. It does not say whether these dates are actual or estimated.

Results were first posted in Apr 2010, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 12, 2007
First posted
Mar 14, 2007
Start
Mar 2007
Primary completionActual
Mar 2009
CompletionActual
Jul 2009
Results first posted
Apr 20, 2010
Last update
Apr 27, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00447278
Lead sponsor
Eli Lilly and Company
First posted
Mar 14, 2007
Start date
Mar 2007
Primary completion
Mar 2009
Completion
Jul 2009
Results posted
Apr 20, 2010
Last update
Apr 27, 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
View the source record on ClinicalTrials.gov ↗

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