Trial Outcomes & Findings for Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT00191945)

NCT ID: NCT00191945

Last Updated: 2010-02-02

Results Overview

Measures the 18 symptoms contained in the DSM-IV 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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 151 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2010-02-02

Participant Flow

158 patients enrolled during the Screening Period (Visits 1 and 2), but 7 did not receive study drug and are not included in the 151 patients randomized in the Double-Blind Period.

Participant milestones

Measure	Atomoxetine Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Double-Blind Acute Treatment STARTED	100	51
Double-Blind Acute Treatment COMPLETED	94	48
Double-Blind Acute Treatment NOT COMPLETED	6	3
Open-Label Treatment Extension STARTED	94	48
Open-Label Treatment Extension COMPLETED	94	48
Open-Label Treatment Extension NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Atomoxetine Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Double-Blind Acute Treatment Parent's Decision	3	0
Double-Blind Acute Treatment Lost to Follow-up	0	1
Double-Blind Acute Treatment Non Protocol Compliance	3	0
Double-Blind Acute Treatment Physician Decision	0	2

Baseline Characteristics

Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Measure	Atomoxetine n=100 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=51 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Total n=151 Participants Total of all reporting groups
Age Continuous	10.3 years STANDARD_DEVIATION 2.48 • n=5 Participants	10.3 years STANDARD_DEVIATION 2.43 • n=7 Participants	10.3 years STANDARD_DEVIATION 2.46 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants	41 Participants n=7 Participants	120 Participants n=5 Participants
Region of Enrollment Spain	100 participants n=5 Participants	51 participants n=7 Participants	151 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder Subtype Inattentive	30 participants n=5 Participants	19 participants n=7 Participants	49.0 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder Subtype Hyperactive	5 participants n=5 Participants	1 participants n=7 Participants	6.0 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder Subtype Combined (Hyperactive-Inattentive)	64 participants n=5 Participants	30 participants n=7 Participants	94.0 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder Subtype Not Assessed	1 participants n=5 Participants	1 participants n=7 Participants	2.0 participants n=5 Participants
Race/Ethnicity Caucasian	98 participants n=5 Participants	47 participants n=7 Participants	145 participants n=5 Participants
Race/Ethnicity African	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity Hispanic	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered	39.1 units on a scale STANDARD_DEVIATION 9.0 • n=5 Participants	39.5 units on a scale STANDARD_DEVIATION 9.0 • n=7 Participants	39.2 units on a scale STANDARD_DEVIATION 9.0 • n=5 Participants
Blood Pressure Systolic Blood Pressure	101.2 mmHg STANDARD_DEVIATION 10.01 • n=5 Participants	100.5 mmHg STANDARD_DEVIATION 10.01 • n=7 Participants	101.0 mmHg STANDARD_DEVIATION 9.98 • n=5 Participants
Blood Pressure Diastolic Blood Pressure	57.9 mmHg STANDARD_DEVIATION 7.15 • n=5 Participants	58.0 mmHg STANDARD_DEVIATION 7.68 • n=7 Participants	57.9 mmHg STANDARD_DEVIATION 7.31 • n=5 Participants
Body Weight	37.9 kilograms STANDARD_DEVIATION 11.86 • n=5 Participants	37.4 kilograms STANDARD_DEVIATION 12.18 • n=7 Participants	37.7 kilograms STANDARD_DEVIATION 11.93 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Measures the 18 symptoms contained in the DSM-IV 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.

Outcome measures

Measure	Atomoxetine n=99 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=50 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 12 Week Endpoint	26.3 units on a scale Standard Deviation 12.7	34.8 units on a scale Standard Deviation 12.3

SECONDARY outcome

Timeframe: Week 9

Population: Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Measures the 18 symptoms contained in the DSM-IV 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.

Outcome measures

Measure	Atomoxetine n=99 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=50 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 9 Weeks	27.3 units on a scale Standard Deviation 12.3	34.4 units on a scale Standard Deviation 12.0

SECONDARY outcome

Timeframe: Week 6

Population: Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Measures the 18 symptoms contained in the DSM-IV 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.

Outcome measures

Measure	Atomoxetine n=99 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=50 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 6 Weeks	28.7 units on a scale Standard Deviation 12.9	34.4 units on a scale Standard Deviation 12.0

SECONDARY outcome

Timeframe: Week 4

Population: Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Measures the 18 symptoms contained in the DSM-IV 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.

Outcome measures

Measure	Atomoxetine n=99 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=50 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score at 4 Weeks	31.2 units on a scale Standard Deviation 12.0	35.5 units on a scale Standard Deviation 12.0

SECONDARY outcome

Timeframe: week 6 and week 12

Population: Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Measures the 18 symptoms contained in the DSM-IV 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.

Outcome measures

Measure	Atomoxetine n=99 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=50 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12 Week 6	28.7 units on a scale Standard Deviation 12.9	34.4 units on a scale Standard Deviation 12.0
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score Change From Week 6 to Week 12 Week 12	26.3 units on a scale Standard Deviation 12.7	34.8 units on a scale Standard Deviation 12.3

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Intention to Treat analysis. Single item missing scores were imputed with the mean score of the remaining items when computing subscale and total scores.

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).

Outcome measures

Measure	Atomoxetine n=99 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=50 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks) Baseline	5.06 units on a scale Standard Deviation 0.93	5.04 units on a scale Standard Deviation 0.83
Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Changes From Baseline to Visit 7 (12 Weeks) Week 12	3.89 units on a scale Standard Deviation 1.15	4.5 units on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline and Open-Label Endpoint (107 weeks)

Population: Intention to Treat analysis. Last observation carried forward.

Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).

Outcome measures

Measure	Atomoxetine n=140 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks) Baseline	5.1 units on a scale Standard Deviation 0.92	—
Clinical Global Impressions- Attention-Deficit/Hyperactivity Disorder-Severity Change From Baseline to Endpoint (Visit 18) of the Open-Label Extension (107 Weeks) Week 107	3.2 units on a scale Standard Deviation 1.28	—

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intention to Treat analysis. Last observation carried forward.

The CPRS-R:S has 27 items to be completed by the parent to assess behavioral problems related to ADHD. Individual item scores range from 0 (not at all true/never/seldom: lowest impairment) to 3 (very much true/very often/very frequent: highest impairment). The total score is calculated as the sum of all items. Total scores range from 0 to 81.

Outcome measures

Measure	Atomoxetine n=99 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=50 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12) Baseline	54.6 units on a scale Standard Deviation 12.6	54.7 units on a scale Standard Deviation 13.6
Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) Total Score Changes From Baseline to Endpoint (Week 12) Week 12	37.8 units on a scale Standard Deviation 18.7	48.5 units on a scale Standard Deviation 17.4

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Intention to Treat analysis. Last observation carried forward.

Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(Score-4.2382)*10/0.32835]+50. Higher scores mean improvement.

Outcome measures

Measure	Atomoxetine n=99 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=50 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Parent: Satisfaction Baseline	38.0 standard deviation units Standard Deviation 14.9	39.0 standard deviation units Standard Deviation 14.7
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Parent: Comfort Baseline	42.8 standard deviation units Standard Deviation 12.5	44.4 standard deviation units Standard Deviation 11.7
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Parent: Resilience Baseline	42.1 standard deviation units Standard Deviation 11.2	41.8 standard deviation units Standard Deviation 11.6
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Parent: Risk Avoidance Baseline	31.7 standard deviation units Standard Deviation 15.8	34.1 standard deviation units Standard Deviation 15.9
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Parent: Achievement Baseline	33.2 standard deviation units Standard Deviation 9.5	33.1 standard deviation units Standard Deviation 10.8
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Parent: Satisfaction 12 Weeks	40.4 standard deviation units Standard Deviation 12.5	40.0 standard deviation units Standard Deviation 13.8
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Parent: Comfort 12 Weeks	44.6 standard deviation units Standard Deviation 11.4	44.1 standard deviation units Standard Deviation 11.5
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Parent: Resilience 12 Weeks	45.3 standard deviation units Standard Deviation 11.0	42.2 standard deviation units Standard Deviation 10.8
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Parent: Risk Avoidance 12 Weeks	40.5 standard deviation units Standard Deviation 14.8	35.9 standard deviation units Standard Deviation 13.9
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Parent: Achievement 12 Weeks	38.0 standard deviation units Standard Deviation 10.0	34.4 standard deviation units Standard Deviation 10.3
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Child/Adolescent: Satisfaction Baseline	49.2 standard deviation units Standard Deviation 9.2	50.0 standard deviation units Standard Deviation 12.6
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Child/Adolescent: Comfort Baseline	49.9 standard deviation units Standard Deviation 9.6	50.6 standard deviation units Standard Deviation 7.9
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Child/Adolescent: Resilience Baseline	52.0 standard deviation units Standard Deviation 10.8	52.0 standard deviation units Standard Deviation 11.6
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Child/Adolescent: Risk Avoidance Baseline	47.6 standard deviation units Standard Deviation 10.4	49.1 standard deviation units Standard Deviation 11.3
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Child/Adolescent: Achievement Baseline	42.1 standard deviation units Standard Deviation 10.3	44.6 standard deviation units Standard Deviation 10.8
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Child/Adolescent: Satisfaction 12 Weeks	50.6 standard deviation units Standard Deviation 9.2	52.3 standard deviation units Standard Deviation 11.1
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Child/Adolescent: Comfort 12 Weeks	52.7 standard deviation units Standard Deviation 8.2	51.9 standard deviation units Standard Deviation 7.7
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Child/Adolescent: Resilience 12 Weeks	52.4 standard deviation units Standard Deviation 9.5	52.2 standard deviation units Standard Deviation 9.4
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Child/Adolescent: Risk Avoidance 12 Weeks	51.9 standard deviation units Standard Deviation 8.7	49.7 standard deviation units Standard Deviation 11.7
Child Health and Illness Profile (CHIP) Change From Baseline to Endpoint (12 Weeks) Child/Adolescent: Achievement 12 Weeks	45.5 standard deviation units Standard Deviation 10.2	45.7 standard deviation units Standard Deviation 11.5

SECONDARY outcome

Timeframe: Baseline

Population: Intention to Treat analysis. All randomized participants who took at least one dose of study drug.

The K-SADS-PL is a semi-structured interview schedule for assessing psychiatric disorders in children and adolescents. It is used to assess the status of 32 DSM-IV child and adolescent psychiatric diagnosis.

Outcome measures

Measure	Atomoxetine n=99 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=50 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) Participants with any Comorbidity	46 participants	22 participants
Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) Participants with Oppositional Defiant Disorder	28 participants	10 participants
Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) Participants with Tic Disorder	16 participants	9 participants
Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) Participants with Affective Disorders	3 participants	2 participants
Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) Participants with Anxiety Disorders	13 participants	6 participants
Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (K-SADS-PL) Participants with Conduct Disorder	0 participants	0 participants

SECONDARY outcome

Timeframe: Week 107

Population: Intention to Treat analysis. Last observation carried forward.

Measures the 18 symptoms contained in the DSM-IV 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.

Outcome measures

Measure	Atomoxetine n=140 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator Administered and Scored (ADHDRS-IV-Parent:Inv) at 107 Weeks (Open-Label Extension)	21.4 units on a scale Standard Deviation 12.8	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: All randomized participants.

Outcome measures

Measure	Atomoxetine n=100 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=51 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Vital Signs - Systolic Blood Pressure Baseline	98.7 mmHg Standard Deviation 13.0	102.2 mmHg Standard Deviation 11.4
Vital Signs - Systolic Blood Pressure 12 Weeks	102.9 mmHg Standard Deviation 10.2	101.2 mmHg Standard Deviation 11.7

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: All randomized participants.

Outcome measures

Measure	Atomoxetine n=100 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=51 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Vital Signs - Diastolic Blood Pressure Baseline	56.4 mmHg Standard Deviation 9.0	58.2 mmHg Standard Deviation 7.2
Vital Signs - Diastolic Blood Pressure 12 Weeks	59.3 mmHg Standard Deviation 7.1	57.5 mmHg Standard Deviation 8.6

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: All randomized participants.

Outcome measures

Measure	Atomoxetine n=100 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=51 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Vital Signs - Pulse Baseline	75.8 beats per minute Standard Deviation 9.8	77.0 beats per minute Standard Deviation 9.3
Vital Signs - Pulse 12 Weeks	84.5 beats per minute Standard Deviation 12.5	79.0 beats per minute Standard Deviation 9.7

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: All randomized participants.

Outcome measures

Measure	Atomoxetine n=100 Participants Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=51 Participants Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Vital Signs - Weight Baseline	38.0 kilograms Standard Deviation 12.0	37.5 kilograms Standard Deviation 12.3
Vital Signs - Weight 12 Weeks	37.0 kilograms Standard Deviation 11.5	38.9 kilograms Standard Deviation 12.8

Adverse Events

Atomoxetine

Serious events: 0 serious events

Other events: 80 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Atomoxetine n=100 participants at risk Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=51 participants at risk Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Gastrointestinal disorders Vomiting	0.00% 0/100	2.0% 1/51 • Number of events 1
Nervous system disorders Dizziness	0.00% 0/100	2.0% 1/51 • Number of events 1

Other adverse events

Measure	Atomoxetine n=100 participants at risk Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year	Placebo n=51 participants at risk Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
Cardiac disorders Tachycardia	4.0% 4/100 • Number of events 4	5.9% 3/51 • Number of events 3
Gastrointestinal disorders Abdominal pain	17.0% 17/100 • Number of events 20	7.8% 4/51 • Number of events 4
Gastrointestinal disorders Abdominal pain upper	6.0% 6/100 • Number of events 7	3.9% 2/51 • Number of events 2
Gastrointestinal disorders Diarrhoea	4.0% 4/100 • Number of events 4	5.9% 3/51 • Number of events 3
Gastrointestinal disorders Nausea	5.0% 5/100 • Number of events 7	3.9% 2/51 • Number of events 2
Gastrointestinal disorders Vomiting	14.0% 14/100 • Number of events 22	13.7% 7/51 • Number of events 7
General disorders Fatigue	10.0% 10/100 • Number of events 11	2.0% 1/51 • Number of events 1
General disorders Pyrexia	7.0% 7/100 • Number of events 8	5.9% 3/51 • Number of events 3
Infections and infestations Ear infection	0.00% 0/100	5.9% 3/51 • Number of events 3
Infections and infestations Nasopharyngitis	7.0% 7/100 • Number of events 8	9.8% 5/51 • Number of events 7
Metabolism and nutrition disorders Decreased appetite	31.0% 31/100 • Number of events 31	7.8% 4/51 • Number of events 4
Nervous system disorders Dizziness	7.0% 7/100 • Number of events 8	3.9% 2/51 • Number of events 2
Nervous system disorders Headache	24.0% 24/100 • Number of events 29	13.7% 7/51 • Number of events 8
Nervous system disorders Somnolence	23.0% 23/100 • Number of events 24	3.9% 2/51 • Number of events 2
Psychiatric disorders Irritability	14.0% 14/100 • Number of events 16	9.8% 5/51 • Number of events 6
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.0% 2/100 • Number of events 2	7.8% 4/51 • Number of events 4

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 1-800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60