Trial Outcomes & Findings for Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD) (NCT NCT00191906)

NCT ID: NCT00191906

Last Updated: 2010-05-25

Results Overview

SSRT measures response execution (go trials) and response inhibition (stop trials). Go trials consist of stimulus (airplane). Child to press response button corresponding to direction airplane is pointing. Stop trials consist of go trial and audible stop signal. Initial delay between go trial and stop signal = 250 msec. If child succeeded in inhibiting response, delay on next stop trial increased by 50 msec, otherwise, delay decreased by 50 msec. SSRT = subtract mean delay from mean go signal reaction time. Lower scores mean better ability to suppress response when presented with stop signal.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

121 participants

Primary outcome timeframe

Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

Results posted on

2010-05-25

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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.
Study Period II STARTED	39	37	27	18
Study Period II COMPLETED	39	32	26	18
Study Period II NOT COMPLETED	0	5	1	0
Study Period III STARTED	14	11	0	0
Study Period III COMPLETED	9	7	0	0
Study Period III NOT COMPLETED	5	4	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Study Period II Adverse Event	0	1	0
Study Period II Withdrawal by Subject	0	3	0
Study Period II Parent/Caregiver Decision	0	1	0
Study Period II Entry Criteria Exclusion	0	0	1
Study Period III Adverse Event	1	0	0
Study Period III Lost to Follow-up	0	1	0
Study Period III Parent/Caregiver Decision	1	0	0
Study Period III Lack of Efficacy	3	3	0

Baseline Characteristics

Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atomoxetine First, Then Placebo n=39 Participants Atomoxetine 1.2 mg/kg/day for 4 weeks, 2 week washout, and then placebo for 4 weeks	Placebo First, Then Atomoxetine n=37 Participants Placebo for 4 weeks, 2 week washout, and then atomoxetine 1.2 mg/kg/day for 4 weeks.	Normal Control n=27 Participants 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 n=18 Participants Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.	Total n=121 Participants Total of all reporting groups
Age Continuous	10.0 years STANDARD_DEVIATION 1.34 • n=5 Participants	9.9 years STANDARD_DEVIATION 1.25 • n=7 Participants	9.9 years STANDARD_DEVIATION 1.01 • n=5 Participants	10.6 years STANDARD_DEVIATION 0.99 • n=4 Participants	10.0 years STANDARD_DEVIATION 1.2 • n=21 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	5 Participants n=4 Participants	38 Participants n=21 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	27 Participants n=7 Participants	17 Participants n=5 Participants	13 Participants n=4 Participants	83 Participants n=21 Participants
Region of Enrollment Belgium	18 participants n=5 Participants	15 participants n=7 Participants	0 participants n=5 Participants	16 participants n=4 Participants	49 participants n=21 Participants
Region of Enrollment Netherlands	21 participants n=5 Participants	22 participants n=7 Participants	27 participants n=5 Participants	2 participants n=4 Participants	72 participants n=21 Participants
Study Arm - Diagnosis ADHD-Combined Type	13 participants n=5 Participants	15 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	28 participants n=21 Participants
Study Arm - Diagnosis Reading Disorder	11 participants n=5 Participants	12 participants n=7 Participants	0 participants n=5 Participants	18 participants n=4 Participants	41 participants n=21 Participants
Study Arm - Diagnosis ADHD-Combined Type + Reading Disorder	15 participants n=5 Participants	10 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	25 participants n=21 Participants
Study Arm - Diagnosis No Disorder	0 participants n=5 Participants	0 participants n=7 Participants	27 participants n=5 Participants	0 participants n=4 Participants	27 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

Population: All efficacy information is summarized and/or presented in data listings based on the Safety sample: Includes all patients who were randomized to double-blind treatment and received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Atomoxetine n=71 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=76 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm ADHD-Combined Type	299.90 milliseconds (msec) Standard Error 13.29	308.82 milliseconds (msec) Standard Error 14.53	—
Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm Reading Disorder	265.61 milliseconds (msec) Standard Error 14.24	260.51 milliseconds (msec) Standard Error 16.02	—
Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm ADHD-C + Reading Disorder	277.38 milliseconds (msec) Standard Error 13.80	292.53 milliseconds (msec) Standard Error 15.46	—
Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm Overall	280.97 milliseconds (msec) Standard Error 7.96	287.29 milliseconds (msec) Standard Error 8.84	—

SECONDARY outcome

Timeframe: Baseline and 4 weeks of therapy

Outcome measures

Outcome measures
Measure	Atomoxetine n=5 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=8 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset	7.95 milliseconds Standard Deviation 48.21	11.22 milliseconds Standard Deviation 62.77	—

SECONDARY outcome

Timeframe: Baseline and 4 weeks of therapy

Outcome measures

Outcome measures
Measure	Atomoxetine n=16 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=13 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control n=14 Participants Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
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	-0.25 milliseconds Standard Deviation 53.41	-34.0 milliseconds Standard Deviation 33.91	0.05 milliseconds Standard Deviation 24.08

SECONDARY outcome

Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

Measure of reaction time to identify whether a word displayed on a computer is a real or correct word versus a pseudo word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying correct words correctly.

Outcome measures

Outcome measures
Measure	Atomoxetine n=68 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=73 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Lexical Decision Task Mean Reaction Time: Correct Words ADHD-Combined Type	1182.9 milliseconds Standard Error 50.23	1291.9 milliseconds Standard Error 38.13	—
Lexical Decision Task Mean Reaction Time: Correct Words Reading Disorder	1172.4 milliseconds Standard Error 51.75	1198.6 milliseconds Standard Error 40.24	—
Lexical Decision Task Mean Reaction Time: Correct Words ADHD-C + Reading Disorder	1201.9 milliseconds Standard Error 51.22	1305.9 milliseconds Standard Error 39.43	—
Lexical Decision Task Mean Reaction Time: Correct Words Overall	1185.7 milliseconds Standard Error 29.49	1265.5 milliseconds Standard Error 22.61	—

SECONDARY outcome

Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

Measure of reaction time to identify whether a word displayed on a computer is a pseudo word versus a real or correct word. During the performance of the lexical decision task that was presented on a computer, the reaction times and accuracy of responses were measured. Data presented are the mean reaction times over the 4 weeks of each therapy for identifying pseudo words correctly.

Outcome measures

Outcome measures
Measure	Atomoxetine n=68 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=73 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Lexical Decision Task Mean Reaction Time: Pseudo Words ADHD-Combined Type	1403.0 milliseconds Standard Error 63.72	1475.4 milliseconds Standard Error 50.08	—
Lexical Decision Task Mean Reaction Time: Pseudo Words Reading Disorder	1365.0 milliseconds Standard Error 65.62	1412.2 milliseconds Standard Error 52.90	—
Lexical Decision Task Mean Reaction Time: Pseudo Words ADHD-C + Reading Disorder	1426.1 milliseconds Standard Error 64.83	1487.0 milliseconds Standard Error 51.73	—
Lexical Decision Task Mean Reaction Time: Pseudo Words Overall	1398.0 milliseconds Standard Error 37.33	1458.2 milliseconds Standard Error 29.63	—

SECONDARY outcome

Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

Measures the visuo-spatial working memory span, and corresponds to the longest sequence of blocks that has been reproduced correctly at least once. Scores can range from 3 to 8, with the higher score indicating better function.

Outcome measures

Outcome measures
Measure	Atomoxetine n=69 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=73 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Working Memory by Corsi Block Tapping Test (CBTT) ADHD-Combined Type	5.29 blocks correctly sequenced Standard Error 0.22	4.98 blocks correctly sequenced Standard Error 0.21	—
Working Memory by Corsi Block Tapping Test (CBTT) Reading Disorder	5.50 blocks correctly sequenced Standard Error 0.23	5.14 blocks correctly sequenced Standard Error 0.23	—
Working Memory by Corsi Block Tapping Test (CBTT) ADHD-C + Reading Disorder	5.92 blocks correctly sequenced Standard Error 0.23	5.29 blocks correctly sequenced Standard Error 0.23	—
Working Memory by Corsi Block Tapping Test (CBTT) Overall	5.57 blocks correctly sequenced Standard Error 0.13	5.14 blocks correctly sequenced Standard Error 0.13	—

SECONDARY outcome

Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

Outcome measures

Outcome measures
Measure	Atomoxetine n=46 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=47 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score ADHD-Combined Type	30.86 units on a scale Standard Error 2.14	35.20 units on a scale Standard Error 1.78	—
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score ADHD-Combined Type + Reading Disorder	22.44 units on a scale Standard Error 2.38	35.17 units on a scale Standard Error 2.07	—
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score Overall	26.65 units on a scale Standard Error 1.60	35.18 units on a scale Standard Error 1.34	—

SECONDARY outcome

Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

Measures the degree of inattention symptoms based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often), for a total Inattention Subscale score range of 0 to 27.

Outcome measures

Outcome measures
Measure	Atomoxetine n=46 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=47 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale ADHD-Combined Type	15.27 units on a scale Standard Error 1.09	17.82 units on a scale Standard Error 0.93	—
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale ADHD-Combined Type + Reading Disorder	12.25 units on a scale Standard Error 1.22	18.28 units on a scale Standard Error 1.09	—
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale Overall	13.76 units on a scale Standard Error 0.82	18.05 units on a scale Standard Error 0.70	—

SECONDARY outcome

Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

Measures the degree of hyperactivity-impulsivity symptoms, based on answers to 9 items. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often) for a total Hyperactivity-Impulsivity Subscale score of 0 to 27.

Outcome measures

Outcome measures
Measure	Atomoxetine n=46 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=47 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale ADHD-Combined Type	15.51 units on a scale Standard Error 1.14	17.24 units on a scale Standard Error 0.96	—
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale ADHD-Combined Type + Reading Disorder	10.32 units on a scale Standard Error 1.27	17.03 units on a scale Standard Error 1.12	—
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale Overall	12.91 units on a scale Standard Error 0.85	17.13 units on a scale Standard Error 0.73	—

SECONDARY outcome

Timeframe: Baseline and Week 4 of initial therapy and Week 4 of crossover therapy

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 score is computed as the sum of the scores on each of the 18 items. Total score is the sum of the scores on the 18 items and range from 0 to 54. Total T-score = (Total Score - 50)/10. Total T-score ranges from -5 (low severity) to 0.4 (high severity).

Outcome measures

Outcome measures
Measure	Atomoxetine n=46 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=47 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score ADHD-Combined Type	-1.91 T-Score of units on a scale Standard Error 0.21	-1.48 T-Score of units on a scale Standard Error 0.18	—
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score ADHD-Combined Type + Reading Disorder	-2.76 T-Score of units on a scale Standard Error 0.24	-1.48 T-Score of units on a scale Standard Error 0.21	—
Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score Overall	-2.34 T-Score of units on a scale Standard Error 0.16	-1.48 T-Score of units on a scale Standard Error 0.13	—

SECONDARY outcome

Timeframe: 4 week therapy endpoint

Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened).

Outcome measures

Outcome measures
Measure	Atomoxetine n=47 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=52 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale ADHD-Combined Type	3.69 units on a scale Standard Error 0.24	3.70 units on a scale Standard Error 0.23	—
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale ADHD-Combined Type + Reading Disorder	2.98 units on a scale Standard Error 0.24	3.76 units on a scale Standard Error 0.24	—
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale Overall	3.34 units on a scale Standard Error 0.17	3.73 units on a scale Standard Error 0.16	—

SECONDARY outcome

Timeframe: 4 week therapy endpoint

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

Outcome measures
Measure	Atomoxetine n=47 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=52 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale ADHD-Combined Type	4.05 units on a scale Standard Error 0.21	3.73 units on a scale Standard Error 0.19	—
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale ADHD-Combined Type + Reading Disorder	3.65 units on a scale Standard Error 0.21	4.34 units on a scale Standard Error 0.20	—
Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale Overall	3.85 units on a scale Standard Error 0.14	4.04 units on a scale Standard Error 0.13	—

SECONDARY outcome

Timeframe: Baseline and 4 weeks of therapy

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudohomophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.

Outcome measures

Outcome measures
Measure	Atomoxetine n=5 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=6 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones	-230.40 milliseconds Standard Deviation 239.43	-339.17 milliseconds Standard Deviation 176.32	—

SECONDARY outcome

Timeframe: Baseline and 4 weeks of therapy

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying pseudo words correctly.

Outcome measures

Outcome measures
Measure	Atomoxetine n=5 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=6 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words	-523.20 milliseconds Standard Deviation 524.36	-536.00 milliseconds Standard Deviation 303.27	—

SECONDARY outcome

Timeframe: Baseline and 4 weeks of therapy

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to identifying psuedohomophones correctly.

Outcome measures

Outcome measures
Measure	Atomoxetine n=16 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=13 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control n=14 Participants Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
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	-170.81 milliseconds Standard Deviation 243.33	-241.00 milliseconds Standard Deviation 317.47	-254.86 milliseconds Standard Deviation 266.46

SECONDARY outcome

Timeframe: Baseline and 4 weeks of therapy

Measure of reaction time in determining whether the stimulus sounds like a real word ('yes' response) or not ('no' response) using pseudo homophones and pseudo words. Data presented here are for reaction time to indentifying pseudo words correctly.

Outcome measures

Outcome measures
Measure	Atomoxetine n=16 Participants Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.	Placebo n=13 Participants Placebo, daily, by mouth for 4 weeks.	Reading Disordered Control n=14 Participants Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
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	-113.06 milliseconds Standard Deviation 432.68	-213.00 milliseconds Standard Deviation 512.33	-368.14 milliseconds Standard Deviation 422.42

Adverse Events

As Randomized Placebo (Crossover)

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

As Randomized Atomoxetine (Crossover)

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Open Label Atomoxetine

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	As Randomized Placebo (Crossover) n=76 participants at risk Patients in either Crossover Period receiving Placebo	As Randomized Atomoxetine (Crossover) n=74 participants at risk Patients in either Crossover Period receiving Atomoxetine	Open Label Atomoxetine n=25 participants at risk Patients in the Open Label extension receiving Atomoxetine
Ear and labyrinth disorders Ear pain	2.6% 2/76 • Number of events 2	1.4% 1/74 • Number of events 1	0.00% 0/25
Eye disorders Eyelid oedema	0.00% 0/76	1.4% 1/74 • Number of events 1	0.00% 0/25
Eye disorders Mydriasis	0.00% 0/76	1.4% 1/74 • Number of events 1	0.00% 0/25
Eye disorders Visual disturbance	0.00% 0/76	1.4% 1/74 • Number of events 1	0.00% 0/25
Gastrointestinal disorders Abdominal pain	2.6% 2/76 • Number of events 2	8.1% 6/74 • Number of events 7	24.0% 6/25 • Number of events 7
Gastrointestinal disorders Abdominal pain upper	3.9% 3/76 • Number of events 4	5.4% 4/74 • Number of events 4	4.0% 1/25 • Number of events 1
Gastrointestinal disorders Diarrhoea	1.3% 1/76 • Number of events 1	5.4% 4/74 • Number of events 4	8.0% 2/25 • Number of events 2
Gastrointestinal disorders Nausea	1.3% 1/76 • Number of events 1	9.5% 7/74 • Number of events 7	12.0% 3/25 • Number of events 4
Gastrointestinal disorders Tooth disorder	1.3% 1/76 • Number of events 1	0.00% 0/74	0.00% 0/25
Gastrointestinal disorders Vomiting	0.00% 0/76	6.8% 5/74 • Number of events 5	8.0% 2/25 • Number of events 3
General disorders Fatigue	2.6% 2/76 • Number of events 2	12.2% 9/74 • Number of events 11	16.0% 4/25 • Number of events 4
General disorders Feeling abnormal	0.00% 0/76	2.7% 2/74 • Number of events 2	0.00% 0/25
General disorders Malaise	0.00% 0/76	2.7% 2/74 • Number of events 2	0.00% 0/25
General disorders Peripheral coldness	1.3% 1/76 • Number of events 1	1.4% 1/74 • Number of events 1	0.00% 0/25
Infections and infestations Gastroenteritis	0.00% 0/76	4.1% 3/74 • Number of events 3	0.00% 0/25
Infections and infestations Gastroenteritis viral	0.00% 0/76	1.4% 1/74 • Number of events 1	0.00% 0/25
Infections and infestations Tonsillitis	0.00% 0/76	1.4% 1/74 • Number of events 1	0.00% 0/25
Injury, poisoning and procedural complications Joint sprain	1.3% 1/76 • Number of events 1	0.00% 0/74	0.00% 0/25
Injury, poisoning and procedural complications Upper limb fracture	1.3% 1/76 • Number of events 1	1.4% 1/74 • Number of events 1	0.00% 0/25
Injury, poisoning and procedural complications Wound	1.3% 1/76 • Number of events 1	1.4% 1/74 • Number of events 1	0.00% 0/25
Metabolism and nutrition disorders Decreased appetite	5.3% 4/76 • Number of events 4	8.1% 6/74 • Number of events 6	28.0% 7/25 • Number of events 7
Musculoskeletal and connective tissue disorders Muscle spasms	1.3% 1/76 • Number of events 1	0.00% 0/74	0.00% 0/25
Nervous system disorders Disturbance in attention	0.00% 0/76	1.4% 1/74 • Number of events 1	0.00% 0/25
Nervous system disorders Dizziness	1.3% 1/76 • Number of events 1	2.7% 2/74 • Number of events 2	0.00% 0/25
Nervous system disorders Headache	13.2% 10/76 • Number of events 11	13.5% 10/74 • Number of events 10	32.0% 8/25 • Number of events 9
Nervous system disorders Poor quality sleep	1.3% 1/76 • Number of events 1	1.4% 1/74 • Number of events 1	0.00% 0/25
Nervous system disorders Syncope	1.3% 1/76 • Number of events 1	1.4% 1/74 • Number of events 1	0.00% 0/25
Psychiatric disorders Apathy	1.3% 1/76 • Number of events 1	2.7% 2/74 • Number of events 2	0.00% 0/25
Psychiatric disorders Eating disorder	1.3% 1/76 • Number of events 1	1.4% 1/74 • Number of events 1	0.00% 0/25
Psychiatric disorders Emotional disorder	0.00% 0/76	1.4% 1/74 • Number of events 1	0.00% 0/25
Psychiatric disorders Fear	1.3% 1/76 • Number of events 1	1.4% 1/74 • Number of events 1	0.00% 0/25
Psychiatric disorders Initial insomnia	1.3% 1/76 • Number of events 1	0.00% 0/74	0.00% 0/25
Psychiatric disorders Negativism	0.00% 0/76	1.4% 1/74 • Number of events 1	0.00% 0/25
Psychiatric disorders Nightmare	1.3% 1/76 • Number of events 1	1.4% 1/74 • Number of events 1	0.00% 0/25
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 1/76 • Number of events 1	0.00% 0/74	0.00% 0/25
Respiratory, thoracic and mediastinal disorders Rhinalgia	1.3% 1/76 • Number of events 1	0.00% 0/74	0.00% 0/25
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/76	1.4% 1/74 • Number of events 1	0.00% 0/25
Skin and subcutaneous tissue disorders Rash erythematous	1.3% 1/76 • Number of events 1	1.4% 1/74 • Number of events 1	0.00% 0/25
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/76	1.4% 1/74 • Number of events 1	0.00% 0/25
Skin and subcutaneous tissue disorders Swelling face	1.3% 1/76 • Number of events 1	0.00% 0/74	0.00% 0/25
Social circumstances Job dissatisfaction	1.3% 1/76 • Number of events 1	1.4% 1/74 • Number of events 1	0.00% 0/25
Vascular disorders Pallor	2.6% 2/76 • Number of events 2	2.7% 2/74 • Number of events 3	0.00% 0/25
Vascular disorders Raynaud's phenomenon	0.00% 0/76	1.4% 1/74 • Number of events 1	0.00% 0/25

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