Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Period I: screening/washout (89 patients screened, 13 screen-failures;45 controls screened). Period II (Visits 2-5): patients received treatment for 4 weeks and then underwent 2-week washout period after which they crossed over to receive the alternate treatment for 4 additional weeks. Period III (Visits 6-12): optional open-label (1 country only).

Reporting Groups

	Description
Atomoxetine First, Then Placebo	Atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks, 2 week washout period and then cross-over to placebo, every day, by mouth for 4 weeks.
Placebo First, Then Atomoxetine	Placebo every day, by mouth for 4 weeks, 2 week washout period and then cross-over to atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks.
Normal Control	Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
Reading Disordered Control	Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.

Participant Flow for 2 periods

Period 1:   Study Period II

	Atomoxetine First, Then Placebo	Placebo First, Then Atomoxetine	Normal Control	Reading Disordered Control
STARTED	39	37	27	18
COMPLETED	39	32	26	18
NOT COMPLETED	0	5	1	0
Adverse Event	0	1	0	0
Withdrawal by Subject	0	3	0	0
Parent/Caregiver Decision	0	1	0	0
Entry Criteria Exclusion	0	0	1	0

Period 2:   Study Period III

	Atomoxetine First, Then Placebo	Placebo First, Then Atomoxetine	Normal Control	Reading Disordered Control
STARTED	14 [1]	11 [1]	0	0
COMPLETED	9	7	0	0
NOT COMPLETED	5	4	0	0
Adverse Event	1	0	0	0
Lost to Follow-up	0	1	0	0
Parent/Caregiver Decision	1	0	0	0
Lack of Efficacy	3	3	0	0

Reporting Groups

	Description
Atomoxetine First, Then Placebo	Atomoxetine 1.2 mg/kg/day for 4 weeks, 2 week washout, and then placebo for 4 weeks
Placebo First, Then Atomoxetine	Placebo for 4 weeks, 2 week washout, and then atomoxetine 1.2 mg/kg/day for 4 weeks.
Normal Control	Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
Reading Disordered Control	Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.

Baseline Measures

	Atomoxetine First, Then Placebo	Placebo First, Then Atomoxetine	Normal Control	Reading Disordered Control	Total
Number of Participants   [units: participants]	39	37	27	18	121
Age   [units: years] Mean ± Standard Deviation	10.0  ± 1.34	9.9  ± 1.25	9.9  ± 1.01	10.6  ± 0.99	10.0  ± 1.2
Gender   [units: participants]
Female	13	10	10	5	38
Male	26	27	17	13	83
Region of Enrollment   [units: participants]
Belgium	18	15	0	16	49
Netherlands	21	22	27	2	72
Study Arm - Diagnosis   [units: participants]
ADHD-Combined Type	13	15	0	0	28
Reading Disorder	11	12	0	18	41
ADHD-Combined Type + Reading Disorder	15	10	0	0	25
No Disorder	0	0	27	0	27

1.  Primary:

Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm   [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ]

2.  Secondary:

Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset   [ Time Frame: Baseline and 4 weeks of therapy ]

3.  Secondary:

Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset   [ Time Frame: Baseline and 4 weeks of therapy ]

4.  Secondary:

Lexical Decision Task Mean Reaction Time: Correct Words   [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ]

5.  Secondary:

Lexical Decision Task Mean Reaction Time: Pseudo Words   [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ]

6.  Secondary:

Working Memory by Corsi Block Tapping Test (CBTT)   [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ]

7.  Secondary:

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score   [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ]

8.  Secondary:

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale   [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ]

9.  Secondary:

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale   [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ]

10.  Secondary:

Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score   [ Time Frame: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy ]

11.  Secondary:

Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale   [ Time Frame: 4 week therapy endpoint ]

12.  Secondary:

Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale   [ Time Frame: 4 week therapy endpoint ]

13.  Secondary:

Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones   [ Time Frame: Baseline and 4 weeks of therapy ]

14.  Secondary:

Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words   [ Time Frame: Baseline and 4 weeks of therapy ]

15.  Secondary:

Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones   [ Time Frame: Baseline and 4 weeks of therapy ]

16.  Secondary:

Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words   [ Time Frame: Baseline and 4 weeks of therapy ]