Trial Outcomes & Findings for Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD) (NCT NCT00760747)

NCT ID: NCT00760747

Last Updated: 2011-09-01

Results Overview

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 (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 112 participants
• Primary outcome timeframe: Baseline, 10 weeks
• Results posted on: 2011-09-01

Participant Flow

Study Period II was a 10-week treatment period. Study Period III was a 4-week period, during which participants continued on atomoxetine treatment in the same dose as given at the end of Study Period II or in a higher dose, up to a maximum of 1.8 mg/kg/day.

Participant milestones

Measure	Slow Switching Group Switch from full stimulant dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day), orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Study Period II STARTED	57	55
Study Period II Received at Least One Dose of Study Drug	57	54
Study Period II COMPLETED	44	41
Study Period II NOT COMPLETED	13	14
Study Period III STARTED	44	41
Study Period III COMPLETED	41	38
Study Period III NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Slow Switching Group Switch from full stimulant dose to atomoxetine 1.2 milligrams per kilogram per day (mg/kg/day), orally (PO), during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Study Period II Adverse Event	3	4
Study Period II Lack of Efficacy	0	6
Study Period II Parent/Caregiver Decision	3	0
Study Period II Protocol Violation	6	3
Study Period II Withdrawal by Subject	1	0
Study Period II No drug administered	0	1
Study Period III Adverse Event	1	0
Study Period III Lack of Efficacy	1	0
Study Period III Parent/Caregiver Decision	0	1
Study Period III Protocol Violation	1	1
Study Period III Physician Decision	0	1

Baseline Characteristics

Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)

Baseline characteristics by cohort

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.	Total n=111 Participants Total of all reporting groups
Age Continuous	11.1 years STANDARD_DEVIATION 2.51 • n=5 Participants	12.0 years STANDARD_DEVIATION 2.16 • n=7 Participants	11.5 years STANDARD_DEVIATION 2.38 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	44 Participants n=7 Participants	93 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	46 Participants n=5 Participants	43 Participants n=7 Participants	89 Participants n=5 Participants
Race/Ethnicity, Customized African	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment Mexico	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Australia	7 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants	7 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Spain	29 participants n=5 Participants	28 participants n=7 Participants	57 participants n=5 Participants
Region of Enrollment Portugal	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Attention Deficit Hyperactivity Disorder (ADHD) subtype Combined	38 participants n=5 Participants	36 participants n=7 Participants	74 participants n=5 Participants
Attention Deficit Hyperactivity Disorder (ADHD) subtype Hyperactive/Impulsive	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants
Attention Deficit Hyperactivity Disorder (ADHD) subtype Inattentive	17 participants n=5 Participants	15 participants n=7 Participants	32 participants n=5 Participants
Attention Deficit Hyperactivity Disorder (ADHD) subtype Not otherwise categorized	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 10 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.

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 (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.

Outcome measures

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Change From Baseline in Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS-IV) Parent Version: Investigator Administered and Scored - Total Score at Week 10 Endpoint	-14.3 units on a scale Standard Error 1.2	-15.0 units on a scale Standard Error 1.2

PRIMARY outcome

Timeframe: Baseline, 2 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.

Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. Higher score indicates greater severity of disease. Least squares means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.

Outcome measures

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Change From Baseline in ADHD-RS-IV Parent Version: Investigator Administered and Scored - Total Score at Week 2 Endpoint	-8.0 units on a scale Standard Error 1.0	-8.1 units on a scale Standard Error 1.0

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.

The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.

Outcome measures

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale - Patient Total Score at Week 10 Endpoint	-0.6 units on a scale Standard Error 0.2	-0.4 units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.

The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.

Outcome measures

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Parent Total Score at Week 10 Endpoint	-1.0 units on a scale Standard Error 0.2	-0.8 units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.

The GIPD scale is a 5-item rating of ADHD-related difficulties (overall difficulties perceived in the morning, during school, during homework, in the evening, and over the entire day and night). For each item, difficulties during the past week are rated on a 7-point scale (1 = normal, not difficult at all; 7 = extremely difficult) and the mean of the 5 items is reported. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.

Outcome measures

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Change From Baseline in Global Impression of Perceived Difficulties (GIPD) Rating Scale- Investigator Total Score at Week 10 Endpoint	-1.3 units on a scale Standard Error 0.2	-1.2 units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.

The CGI- S is a single-item clinician rating of the severity of the participant's ADHD symptoms in relation to the clinician's total experience of ADHD participants. Severity is rated on a seven-point scale (1 = normal, not ill at all; 7 = among the most extremely ill patients). Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.

Outcome measures

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Change From Baseline in Clinical Global Impression Severity (CGI-S) Rating Scale - Total Score at Week 10 Endpoint	-1.7 units on a scale Standard Error 0.2	-1.7 units on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.

CHIP-CE-PRF consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format. Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation (SD) of 10. Standard scores are expressed in SD units. T-score=[(Score- Mean for the reference population [Ref Pop])*10/SD for the Ref Pop]+50. Higher scores mean better quality of life. Least square means are adjusted for baseline, site, treatment, visit and treatment by visit interaction.

Outcome measures

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint Satisfaction Domain	3.4 standard deviation units Standard Error 1.6	2.2 standard deviation units Standard Error 1.6
Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint Comfort Domain	0.7 standard deviation units Standard Error 1.2	4.1 standard deviation units Standard Error 1.1
Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint Risk Avoidance Domain	4.9 standard deviation units Standard Error 1.4	2.9 standard deviation units Standard Error 1.4
Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint Resilience Domain	1.8 standard deviation units Standard Error 1.4	-1.0 standard deviation units Standard Error 1.4
Change From Baseline in Child Health and Illness Profile Child Edition-Parent Report Form (CHIP-CE-PRF) - Domain Scores at Week 10 Endpoint Achievement Domain	3.5 standard deviation units Standard Error 1.7	-1.2 standard deviation units Standard Error 1.6

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment. Last Observation Carried Forward (LOCF).

The Treatment Satisfaction Survey consists of a five-question survey each rated on a 5 point scale (0=very satisfied/very likely, 4=very dissatisfied/not at all likely). The mean score over the items is reported.

Outcome measures

Measure	Slow Switching Group n=53 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=53 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Change From Baseline in Treatment Satisfaction Preference Survey Mean Score at Week 10 Endpoint	-0.7 units on a scale Standard Deviation 1.16	-0.5 units on a scale Standard Deviation 1.11

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 14 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.

Outcome measures

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint Week 6 Change Diastolic BP (n=52, 52)	1.5 mmHg Standard Deviation 7.21	1.9 mmHg Standard Deviation 8.31
Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint Week 6 Change Systolic BP (n=52, 52)	1.2 mmHg Standard Deviation 7.74	0.5 mmHg Standard Deviation 9.05
Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint Week 14 Change Diastolic BP (n=43, 40)	2.3 mmHg Standard Deviation 7.58	3.1 mmHg Standard Deviation 7.04
Change From Baseline in Blood Pressure (BP) at Week 6 and Week 14 Endpoint Week 14 Change Systolic BP (n= 43, 40)	-0.2 mmHg Standard Deviation 8.62	2.6 mmHg Standard Deviation 9.00

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 14 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.

Outcome measures

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint Week 6 Change (n=52, 52)	6.8 beats per minute Standard Deviation 11.12	4.2 beats per minute Standard Deviation 8.83
Change From Baseline in Pulse Rate at Week 6 and Week 14 Endpoint Week 14 Change (n=43, 40)	3.4 beats per minute Standard Deviation 12.69	5.9 beats per minute Standard Deviation 10.17

SECONDARY outcome

Timeframe: Baseline, 6 weeks, 14 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment, and with both baseline and week 6 or 14 values.

Outcome measures

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint Week 6 Change (n=52, 52)	-0.4 kilogram Standard Deviation 1.12	0.6 kilogram Standard Deviation 1.25
Change From Baseline in Body Weight at Week 6 and Week 14 Endpoint Week 14 Change (n=43, 40)	0.6 kilogram Standard Deviation 1.64	1.1 kilogram Standard Deviation 2.15

SECONDARY outcome

Timeframe: Baseline through 14 weeks

Population: Intention to treat (ITT) population includes all randomized participants who received at least 1 dose of study drug, that is, they have a non-missing dose for atomoxetine study treatment.

Columbia Suicide Rating Scale (C-SSRS): scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.

Outcome measures

Measure	Slow Switching Group n=57 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 Participants Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Number of Participants With Suicidal Behaviors and Ideations	1 participants	1 participants

Adverse Events

Slow Switching Group

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Fast Switching Group

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Slow Switching Group n=57 participants at risk Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 participants at risk Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Nervous system disorders VIth nerve paralysis	1.8% 1/57 • Number of events 1	0.00% 0/54
Psychiatric disorders Suicide attempt	0.00% 0/57	1.9% 1/54 • Number of events 1
Skin and subcutaneous tissue disorders Rash	1.8% 1/57 • Number of events 1	0.00% 0/54

Other adverse events

Measure	Slow Switching Group n=57 participants at risk Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 10 weeks then continue treatment up to 1.8mg/kg/day, PO to 14 weeks.	Fast Switching Group n=54 participants at risk Switch from full stimulant dose to atomoxetine 1.2mg/kg/day, PO, during 2 weeks. Continue atomoxetine 1.2 mg/kg/day to 10 weeks, followed by atomoxetine up to 1.8 mg/kg/day to 14 weeks.
Gastrointestinal disorders Abdominal pain	5.3% 3/57 • Number of events 3	11.1% 6/54 • Number of events 13
Gastrointestinal disorders Abdominal pain upper	14.0% 8/57 • Number of events 11	9.3% 5/54 • Number of events 5
Gastrointestinal disorders Nausea	7.0% 4/57 • Number of events 4	0.00% 0/54
Gastrointestinal disorders Vomiting	1.8% 1/57 • Number of events 1	9.3% 5/54 • Number of events 6
General disorders Fatigue	5.3% 3/57 • Number of events 3	7.4% 4/54 • Number of events 4
General disorders Irritability	7.0% 4/57 • Number of events 5	5.6% 3/54 • Number of events 3
General disorders Pyrexia	7.0% 4/57 • Number of events 4	3.7% 2/54 • Number of events 3
Infections and infestations Nasopharyngitis	12.3% 7/57 • Number of events 8	5.6% 3/54 • Number of events 3
Infections and infestations Upper respiratory tract infection	5.3% 3/57 • Number of events 3	0.00% 0/54
Metabolism and nutrition disorders Decreased appetite	19.3% 11/57 • Number of events 12	13.0% 7/54 • Number of events 7
Nervous system disorders Headache	19.3% 11/57 • Number of events 16	22.2% 12/54 • Number of events 19
Nervous system disorders Somnolence	7.0% 4/57 • Number of events 4	16.7% 9/54 • Number of events 9
Psychiatric disorders Insomnia	1.8% 1/57 • Number of events 1	5.6% 3/54 • Number of events 3
Respiratory, thoracic and mediastinal disorders Cough	5.3% 3/57 • Number of events 4	1.9% 1/54 • Number of events 2

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

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

Restriction type: GT60