Trial Outcomes & Findings for Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR (NCT NCT00393042)

NCT ID: NCT00393042

Last Updated: 2017-04-19

Results Overview

Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep. The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 77 participants
• Primary outcome timeframe: 8-10 weeks
• Results posted on: 2017-04-19

Participant Flow

Eligible participants were recruited from the investigators' practices, clinic referrals, and radio advertisements. Participants were enrolled between January 2007 and January 2009.

7 participants didn't want to participate after screening, 1 didn't meet criteria, 1 ADHD was not the primary condition, 1 showed an abnormal lab/physical/EKG, 1 was unable to swallow pills, 1 had an exclusionary medical condition, 1 was removed due to protocol violations.

Participant milestones

Measure	Focalin XR Then Adderall XR Focalin XR first for 4 weeks (3 dose levels and placebo) then Adderall XR for 4 weeks (3 dose levels and placebo).	Adderall XR Then Focalin XR Adderall XR first for 4 weeks (3 dose levels and placebo) then Focalin XR for 4 weeks (3 dose levels and placebo).
First Intervention STARTED	31	33
First Intervention Completed the Placebo Dosage	27	29
First Intervention Completed 10mg Dosage	29	29
First Intervention Completed 20 mg Dosage	26	28
First Intervention Completed 25/30mg Dosage	27	27
First Intervention COMPLETED	26	27
First Intervention NOT COMPLETED	5	6
Second Intervetion STARTED	26	27
Second Intervetion Completed Placebo Dosage	25	21
Second Intervetion Completed 10 mg Dosage	26	24
Second Intervetion Completed the 20mg Dosage	24	21
Second Intervetion Completed 25/30 mg Dosage	24	20
Second Intervetion COMPLETED	24	19
Second Intervetion NOT COMPLETED	2	8

Reasons for withdrawal

Measure	Focalin XR Then Adderall XR Focalin XR first for 4 weeks (3 dose levels and placebo) then Adderall XR for 4 weeks (3 dose levels and placebo).	Adderall XR Then Focalin XR Adderall XR first for 4 weeks (3 dose levels and placebo) then Focalin XR for 4 weeks (3 dose levels and placebo).
First Intervention Withdrawal by Subject	1	2
First Intervention Lost to Follow-up	3	3
First Intervention Protocol Violation	1	0
First Intervention Adverse Event	0	1
Second Intervetion Adverse Event	0	3
Second Intervetion Withdrawal by Subject	0	2
Second Intervetion Lack of Efficacy	1	0
Second Intervetion Lost to Follow-up	0	2
Second Intervetion Protocol Violation	1	1

Baseline Characteristics

Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR

Baseline characteristics by cohort

Measure	Overall Study n=64 Participants Participants either Adderall XR or Focalin XR for four weeks (3 dose levels and placebo) followed by four weeks (3 dose levels and placebo) of the opposite medication they received the first four weeks. Baseline Measures are based off all participants that were randomized regardless of the order they received the medication. Since we were interested in evaluating efficacy and adverse events at all dose conditions, participants were included in analysis if they received at least 2 weeks of study drug to insure that all participants had been exposed to at least one week of active drug
Age, Categorical <=18 years	64 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	11.7 years STANDARD_DEVIATION 2.24 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants

PRIMARY outcome

Timeframe: 8-10 weeks

Population: Subjects with complete and valid actigraphy (n = 37) and sleep diaries were used to calculate sleep onset latency and sleep duration.

Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep. The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.

Outcome measures

Measure	Placebo n=37 Participants Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.	10mg of Either Focalin XR or Adderall XR n=37 Participants Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.	20mg of Either Focalin XR or Adderall XR n=37 Participants Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.	25/30mg of Either Focalin XR or Adderall XR n=37 Participants Each participant received 25 or 30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.	Adderall XR All Dose Levels n=37 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.	Focalin XR All Dose Levels n=37 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.	Focalin XR - 20 mg This is the 20 mg dosage week for the Focalin XR medication.	Focalin XR - 25/30mg This is the 25/30 mg dosage week for the Focalin XR medication.	9/10 Allele: Placebo of Adderall XR This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Adderall XR This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Adderall XR This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Adderall XR This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: Placebo of Focalin XR This is the Placebo dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Focalin XR This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Focalin XR This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Focalin XR This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	10/10 Allele: Placebo of Adderall XR This is the Placebo dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Adderall XR This is the 10 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Adderall XR This is the 20 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30 mg of Adderall XR This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: Placebo of Focalin XR This is the Placebo dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Focalin XR This is the 10 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Focalin XR This is the 20 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30mg of Focaling XR This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. Sleep start time	2249 HHMM.SS Standard Deviation 0012.19	2304 HHMM.SS Standard Deviation 0010.40	2319 HHMM.SS Standard Deviation 0012.21	2325 HHMM.SS Standard Deviation 0011.17	2309 HHMM.SS Standard Deviation 0011.05	2309 HHMM.SS Standard Deviation 0011.19	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. Sleep End time	0742 HHMM.SS Standard Deviation 0015.36	0728 HHMM.SS Standard Deviation 0009.54	0735 HHMM.SS Standard Deviation 0010.46	0732 HHMM.SS Standard Deviation 0011.09	0735 HHMM.SS Standard Deviation 0010.40	0734 HHMM.SS Standard Deviation 0010.04	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 8-10 weeks

Population: participants with sufficient sleep actigraphy data for analysis (n=37)

Actigraphs (AW64 series) were worn each night and were used to assess participant's sleep patterns in their natural home environment. These computerized wristwatch-like devices collect data generated by movements. They are minimally invasive and allow sleep to be recorded reliably without interfering with the family's routine. One-minute epochs were used to analyze actigraphic sleep sata. Bedtimes and wake times were reported for each participant using sleep logs, and these times were used as the start and end times for the analyses. For each 1-min epoch, the total sum of activity counts were computed. If they exceeded a threshold (threshold sensitivity value = mean score in active period/45), then the epoch was considered waking. If it fell below that threshold, then it was considered sleep.The data for Adderall XR and Focalin XR was combined to look at the cumulative effects that medication has on sleep.

Outcome measures

Measure	Placebo n=37 Participants Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.	10mg of Either Focalin XR or Adderall XR n=37 Participants Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.	20mg of Either Focalin XR or Adderall XR n=37 Participants Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.	25/30mg of Either Focalin XR or Adderall XR n=37 Participants Each participant received 25 or 30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.	Adderall XR All Dose Levels n=37 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.	Focalin XR All Dose Levels n=37 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.	Focalin XR - 20 mg This is the 20 mg dosage week for the Focalin XR medication.	Focalin XR - 25/30mg This is the 25/30 mg dosage week for the Focalin XR medication.	9/10 Allele: Placebo of Adderall XR This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Adderall XR This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Adderall XR This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Adderall XR This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: Placebo of Focalin XR This is the Placebo dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Focalin XR This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Focalin XR This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Focalin XR This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	10/10 Allele: Placebo of Adderall XR This is the Placebo dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Adderall XR This is the 10 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Adderall XR This is the 20 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30 mg of Adderall XR This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: Placebo of Focalin XR This is the Placebo dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Focalin XR This is the 10 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Focalin XR This is the 20 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30mg of Focaling XR This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
Sleep Duration	459.6 minutes Standard Deviation 73.6	446.7 minutes Standard Deviation 63.58	432.17 minutes Standard Deviation 64.6	425.5 minutes Standard Deviation 61.5	438.82 minutes Standard Deviation 67.2	443.2 minutes Standard Deviation 66.9	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: completed weekly over 8-10 weeks

Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.

Outcome measures

Measure	Placebo n=48 Participants Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.	10mg of Either Focalin XR or Adderall XR n=53 Participants Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.	20mg of Either Focalin XR or Adderall XR n=47 Participants Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.	25/30mg of Either Focalin XR or Adderall XR n=47 Participants Each participant received 25 or 30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.	Adderall XR All Dose Levels n=54 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.	Focalin XR All Dose Levels n=55 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.	Focalin XR - 20 mg n=52 Participants This is the 20 mg dosage week for the Focalin XR medication.	Focalin XR - 25/30mg n=51 Participants This is the 25/30 mg dosage week for the Focalin XR medication.	9/10 Allele: Placebo of Adderall XR This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Adderall XR This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Adderall XR This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Adderall XR This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: Placebo of Focalin XR This is the Placebo dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Focalin XR This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Focalin XR This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Focalin XR This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	10/10 Allele: Placebo of Adderall XR This is the Placebo dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Adderall XR This is the 10 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Adderall XR This is the 20 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30 mg of Adderall XR This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: Placebo of Focalin XR This is the Placebo dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Focalin XR This is the 10 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Focalin XR This is the 20 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30mg of Focaling XR This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
ADHD Parent Rating Scale-IV Inattention Symptom Subscale Scores	16.61 units on a scale Standard Deviation 7.8	6.40 units on a scale Standard Deviation 8.55	12.2 units on a scale Standard Deviation 8.08	12.74 units on a scale Standard Deviation 8.38	17.31 units on a scale Standard Deviation 8.23	17.51 units on a scale Standard Deviation 7.03	13.33 units on a scale Standard Deviation 7.08	12.11 units on a scale Standard Deviation 8.72	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
ADHD Parent Rating Scale-IV Hyperactivity/Impulsivity Symptom subscale scores	11.41 units on a scale Standard Deviation 8.55	10.78 units on a scale Standard Deviation 7.60	7.92 units on a scale Standard Deviation 6.78	7.67 units on a scale Standard Deviation 6.62	13.24 units on a scale Standard Deviation 8.91	10.84 units on a scale Standard Deviation 7.37	8.49 units on a scale Standard Deviation 7.37	8.49 units on a scale Standard Deviation 6.70	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
ADHD Parent Rating Scale-IV Total Symptoms scores	28.02 units on a scale Standard Deviation 15.15	27.15 units on a scale Standard Deviation 14.49	20.12 units on a scale Standard Deviation 13.87	20.40 units on a scale Standard Deviation 13.68	30.58 units on a scale Standard Deviation 15.33	28.35 units on a scale Standard Deviation 12.74	21.82 units on a scale Standard Deviation 12.72	20.41 units on a scale Standard Deviation 13.61	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 8-10 weeks

Population: The number of participants analyzed differs from the participant flow because some participants refused to provide a DNA sample for analysis or some participants did not have the allele type that was being observed. Of those that provided a DNA sample, 6 had the 9/9 allele on the DAT 1 gene, 15 had the 9/10 allele and 30 had the 10/10 allele.

Three variations of the DAT 1 gene were observed, the 9/9 allele, the 9/10 allele and the 10/10 allele. The ADHD Rating Scale (ADHD-RS) and Clinical Global Impressions - Severity (CGI-S) measures were used to evaluate how the DAT 1 gene allele type altered the efficacy of the medication. The DAT 1 genotype did not predict differential response to Focalin XR or Adderall XR so the dose levels of each drug was combined to examine how the genotype interacted with the dose level. The ADHD-RS evaluates the severity of the participant's ADHD symptoms and includes two subscales: Inattention and Hyperactivity/Impulsivity. Both subscale scores range from 0 to 27 with a higher score representing more severe symptoms. The subscales are summed to calculate the total score which can range from 0 to 54. The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.

Outcome measures

Measure	Placebo n=5 Participants Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.	10mg of Either Focalin XR or Adderall XR n=6 Participants Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.	20mg of Either Focalin XR or Adderall XR n=5 Participants Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.	25/30mg of Either Focalin XR or Adderall XR n=5 Participants Each participant received 25 or 30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.	Adderall XR All Dose Levels n=3 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.	Focalin XR All Dose Levels n=5 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.	Focalin XR - 20 mg n=4 Participants This is the 20 mg dosage week for the Focalin XR medication.	Focalin XR - 25/30mg n=4 Participants This is the 25/30 mg dosage week for the Focalin XR medication.	9/10 Allele: Placebo of Adderall XR n=14 Participants This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Adderall XR n=15 Participants This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Adderall XR n=14 Participants This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Adderall XR n=14 Participants This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: Placebo of Focalin XR n=13 Participants This is the Placebo dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Focalin XR n=15 Participants This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Focalin XR n=12 Participants This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Focalin XR n=10 Participants This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	10/10 Allele: Placebo of Adderall XR n=30 Participants This is the Placebo dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Adderall XR n=30 Participants This is the 10 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Adderall XR n=29 Participants This is the 20 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30 mg of Adderall XR n=26 Participants This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: Placebo of Focalin XR n=27 Participants This is the Placebo dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Focalin XR n=27 Participants This is the 10 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Focalin XR n=27 Participants This is the 20 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30mg of Focaling XR n=26 Participants This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms ADHD-RS Inattention subscale score	18.60 units on a scale Standard Deviation 9.61	18.83 units on a scale Standard Deviation 10.59	19.00 units on a scale Standard Deviation 8.51	15.40 units on a scale Standard Deviation 9.18	19.33 units on a scale Standard Deviation 7.51	22.20 units on a scale Standard Deviation 4.76	16.75 units on a scale Standard Deviation 8.81	12.50 units on a scale Standard Deviation 9.81	18.64 units on a scale Standard Deviation 6.55	16.27 units on a scale Standard Deviation 7.33	15.86 units on a scale Standard Deviation 6.71	13.43 units on a scale Standard Deviation 7.95	18.08 units on a scale Standard Deviation 8.51	16.93 units on a scale Standard Deviation 5.59	13.36 units on a scale Standard Deviation 8.27	13.70 units on a scale Standard Deviation 9.86	15.07 units on a scale Standard Deviation 8.14	16.13 units on a scale Standard Deviation 9.35	9.36 units on a scale Standard Deviation 7.88	11.96 units on a scale Standard Deviation 8.65	16.44 units on a scale Standard Deviation 8.44	16.56 units on a scale Standard Deviation 7.92	12.56 units on a scale Standard Deviation 6.64	11.15 units on a scale Standard Deviation 8.61
Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms ADHD-RS Hyperactivity/Impulsivity subscale score	12.80 units on a scale Standard Deviation 8.90	18.33 units on a scale Standard Deviation 10.03	14.80 units on a scale Standard Deviation 8.07	10.40 units on a scale Standard Deviation 9.96	17.33 units on a scale Standard Deviation 2.52	17.40 units on a scale Standard Deviation 4.77	14.00 units on a scale Standard Deviation 9.13	9.00 units on a scale Standard Deviation 7.07	9.36 units on a scale Standard Deviation 8.95	10.67 units on a scale Standard Deviation 7.74	8.36 units on a scale Standard Deviation 7.04	6.43 units on a scale Standard Deviation 6.95	8.92 units on a scale Standard Deviation 9.38	8.27 units on a scale Standard Deviation 7.23	6.73 units on a scale Standard Deviation 7.04	7.00 units on a scale Standard Deviation 7.02	11.87 units on a scale Standard Deviation 8.76	9.63 units on a scale Standard Deviation 6.83	7.07 units on a scale Standard Deviation 6.18	7.50 units on a scale Standard Deviation 5.70	13.74 units on a scale Standard Deviation 9.19	10.63 units on a scale Standard Deviation 7.14	8.41 units on a scale Standard Deviation 6.34	8.65 units on a scale Standard Deviation 6.46
Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms ADHD-RS total score	31.40 units on a scale Standard Deviation 18.06	37.17 units on a scale Standard Deviation 20.55	33.80 units on a scale Standard Deviation 16.33	25.80 units on a scale Standard Deviation 19.03	36.67 units on a scale Standard Deviation 6.43	39.60 units on a scale Standard Deviation 8.44	30.75 units on a scale Standard Deviation 17.63	24.00 units on a scale Standard Deviation 17.19	28.00 units on a scale Standard Deviation 13.59	26.80 units on a scale Standard Deviation 13.14	24.21 units on a scale Standard Deviation 13.01	19.86 units on a scale Standard Deviation 12.84	27.08 units on a scale Standard Deviation 15.71	25.20 units on a scale Standard Deviation 11.89	20.09 units on a scale Standard Deviation 13.71	20.70 units on a scale Standard Deviation 15.84	26.93 units on a scale Standard Deviation 16.05	25.77 units on a scale Standard Deviation 14.33	16.43 units on a scale Standard Deviation 13.01	19.46 units on a scale Standard Deviation 13.20	30.19 units on a scale Standard Deviation 16.49	27.19 units on a scale Standard Deviation 12.93	20.96 units on a scale Standard Deviation 11.98	19.81 units on a scale Standard Deviation 13.26
Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms CGI-S score	4.40 units on a scale Standard Deviation 0.55	4.33 units on a scale Standard Deviation 1.51	4.80 units on a scale Standard Deviation 1.30	4.00 units on a scale Standard Deviation 1.58	4.67 units on a scale Standard Deviation 0.58	4.60 units on a scale Standard Deviation 0.55	4.50 units on a scale Standard Deviation 1.29	4.00 units on a scale Standard Deviation 1.63	4.36 units on a scale Standard Deviation 1.08	4.07 units on a scale Standard Deviation 1.03	3.71 units on a scale Standard Deviation 1.14	3.50 units on a scale Standard Deviation 1.40	4.31 units on a scale Standard Deviation 0.95	4.27 units on a scale Standard Deviation 0.70	3.58 units on a scale Standard Deviation 1.38	3.90 units on a scale Standard Deviation 1.66	4.17 units on a scale Standard Deviation 1.39	4.07 units on a scale Standard Deviation 1.48	3.21 units on a scale Standard Deviation 1.32	3.54 units on a scale Standard Deviation 1.24	4.15 units on a scale Standard Deviation 1.29	4.19 units on a scale Standard Deviation 0.83	3.52 units on a scale Standard Deviation 1.12	3.31 units on a scale Standard Deviation 1.26

SECONDARY outcome

Timeframe: 8-10 weeks

Population: The number of participants analyzed differs from the participant flow in the Focalin XR groups because the CGI-S was not completed for every participant. The same is true for the Adderall XR - 25/30mg group.

The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.

Outcome measures

Measure	Placebo n=54 Participants Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.	10mg of Either Focalin XR or Adderall XR n=55 Participants Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.	20mg of Either Focalin XR or Adderall XR n=52 Participants Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.	25/30mg of Either Focalin XR or Adderall XR n=48 Participants Each participant received 25 or 30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.	Adderall XR All Dose Levels n=45 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.	Focalin XR All Dose Levels n=51 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.	Focalin XR - 20 mg n=46 Participants This is the 20 mg dosage week for the Focalin XR medication.	Focalin XR - 25/30mg n=44 Participants This is the 25/30 mg dosage week for the Focalin XR medication.	9/10 Allele: Placebo of Adderall XR This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Adderall XR This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Adderall XR This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Adderall XR This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: Placebo of Focalin XR This is the Placebo dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Focalin XR This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Focalin XR This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Focalin XR This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	10/10 Allele: Placebo of Adderall XR This is the Placebo dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Adderall XR This is the 10 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Adderall XR This is the 20 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30 mg of Adderall XR This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: Placebo of Focalin XR This is the Placebo dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Focalin XR This is the 10 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Focalin XR This is the 20 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30mg of Focaling XR This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
Clinical Global Impression - Severity	4.26 units on a scale Standard Deviation 1.18	4.09 units on a scale Standard Deviation 1.29	3.48 units on a scale Standard Deviation 1.34	3.56 units on a scale Standard Deviation 1.27	4.24 units on a scale Standard Deviation 1.13	4.24 units on a scale Standard Deviation 0.76	3.63 units on a scale Standard Deviation 1.20	3.55 units on a scale Standard Deviation 1.35	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 8-10 weeks

Population: The number of participants analyzed differs from the participant flow in all of the groups besides the Adderall XR - 10mg group because the WFIRS was not completed for every participant.

The WFIRS consists of 50 questions where respondents are asked to rate their child's functional impairment. The items of the WFIRS are scored on a four point Likert-type rating scale: 0 (never or not at all), 1 (sometimes or somewhat), 2 (often or much) or 3 (very often or very much) and aggregated to produce six domain scores: Family (ranges between 0-24), Learning or School (ranges between 0-33), Self-Concept (ranges between 0-15), Social Activities (ranges between 0-27), Life Skills (ranges between 0-36), and Risky Activities (ranges between 0-42). The subscales are scored by summing the responses in the subsection. The Total score is the sum of all the responses and it ranges between 0-150. The higher the score in each of the subscales the more impairment is recorded, this is also true for the total score.

Outcome measures

Measure	Placebo n=53 Participants Regardless of the medication the participants were taking, each 4 week period included a randomized placebo week. This data is based off each participant's placebo weeks.	10mg of Either Focalin XR or Adderall XR n=55 Participants Each participant received 10mg of either Focalin XR or Adderall XR. The data collected from the 10mg week of both drugs was combined.	20mg of Either Focalin XR or Adderall XR n=51 Participants Each participant received 20mg of either Focalin XR or Adderall XR. The data collected from the 20mg week of both drugs was combined.	25/30mg of Either Focalin XR or Adderall XR n=47 Participants Each participant received 25 or 30mg of either Focalin XR or Adderall XR depending on their weight. The data collected from the 25/30mg week of both drugs was combined.	Adderall XR All Dose Levels n=44 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Adderall XR.	Focalin XR All Dose Levels n=48 Participants Participants were given 10mg, 20mg, 25/30mg (depending on their weight) and a randomized placebo week for 4 weeks. This data is combines the 10mg, 20mg, and 25/30mg data for Focalin XR.	Focalin XR - 20 mg n=46 Participants This is the 20 mg dosage week for the Focalin XR medication.	Focalin XR - 25/30mg n=42 Participants This is the 25/30 mg dosage week for the Focalin XR medication.	9/10 Allele: Placebo of Adderall XR This is the Placebo dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Adderall XR This is the 10 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Adderall XR This is the 20 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Adderall XR This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 9/10 allele	9/10 Allele: Placebo of Focalin XR This is the Placebo dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 10 mg of Focalin XR This is the 10 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 20 mg of Focalin XR This is the 20 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	9/10 Allele: 25/30 mg of Focalin XR This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 9/10 allele	10/10 Allele: Placebo of Adderall XR This is the Placebo dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Adderall XR This is the 10 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Adderall XR This is the 20 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30 mg of Adderall XR This is the 25/30 mg dosage of Adderall XR medication phase for the participants with the 10/10 allele	10/10 Allele: Placebo of Focalin XR This is the Placebo dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 10 mg of Focalin XR This is the 10 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 20 mg of Focalin XR This is the 20 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele	10/10 Allele: 25/30mg of Focaling XR This is the 25/30 mg dosage of Focalin XR medication phase for the participants with the 10/10 allele
Weiss Functional Impairment Rating Scale (WFIRS) Family subscale score	6.72 units on a scale Standard Deviation 6.13	7.02 units on a scale Standard Deviation 6.41	6.35 units on a scale Standard Deviation 6.10	6.70 units on a scale Standard Deviation 7.14	7.39 units on a scale Standard Deviation 7.14	7.35 units on a scale Standard Deviation 6.09	6.50 units on a scale Standard Deviation 6.42	6.50 units on a scale Standard Deviation 6.46	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weiss Functional Impairment Rating Scale (WFIRS) Learning subscale score	6.74 units on a scale Standard Deviation 5.63	8.75 units on a scale Standard Deviation 6.70	6.86 units on a scale Standard Deviation 6.19	6.21 units on a scale Standard Deviation 5.62	9.30 units on a scale Standard Deviation 6.34	9.25 units on a scale Standard Deviation 5.94	7.54 units on a scale Standard Deviation 5.24	7.39 units on a scale Standard Deviation 5.78	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weiss Functional Impairment Rating Scale (WFIRS) Life skills subscale score	7.43 units on a scale Standard Deviation 4.32	7.91 units on a scale Standard Deviation 4.78	7.44 units on a scale Standard Deviation 4.99	7.34 units on a scale Standard Deviation 4.45	8.30 units on a scale Standard Deviation 4.76	7.65 units on a scale Standard Deviation 4.44	8.30 units on a scale Standard Deviation 5.48	7.60 units on a scale Standard Deviation 5.66	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weiss Functional Impairment Rating Scale (WFIRS) Self-concept subscale score	1.11 units on a scale Standard Deviation 1.46	1.59 units on a scale Standard Deviation 2.05	1.42 units on a scale Standard Deviation 1.80	1.06 units on a scale Standard Deviation 1.61	1.25 units on a scale Standard Deviation 1.97	1.19 units on a scale Standard Deviation 1.47	1.33 units on a scale Standard Deviation 1.61	1.31 units on a scale Standard Deviation 1.97	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weiss Functional Impairment Rating Scale (WFIRS) Social activities subscale score	3.51 units on a scale Standard Deviation 3.53	3.91 units on a scale Standard Deviation 3.81	2.98 units on a scale Standard Deviation 3.10	3.06 units on a scale Standard Deviation 4.05	3.73 units on a scale Standard Deviation 4.14	3.85 units on a scale Standard Deviation 3.57	3.54 units on a scale Standard Deviation 3.40	3.17 units on a scale Standard Deviation 3.98	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weiss Functional Impairment Rating Scale (WFIRS) Risky activities subscale score	2.19 units on a scale Standard Deviation 2.56	1.94 units on a scale Standard Deviation 2.30	2.24 units on a scale Standard Deviation 3.41	1.68 units on a scale Standard Deviation 2.23	1.91 units on a scale Standard Deviation 1.64	1.96 units on a scale Standard Deviation 2.12	1.78 units on a scale Standard Deviation 1.78	1.67 units on a scale Standard Deviation 1.73	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weiss Functional Impairment Rating Scale (WFIRS) Total score	27.70 units on a scale Standard Deviation 17.03	31.06 units on a scale Standard Deviation 18.93	27.32 units on a scale Standard Deviation 19.53	26.23 units on a scale Standard Deviation 19.74	20.91 units on a scale Standard Deviation 17.50	31.13 units on a scale Standard Deviation 17.11	29.20 units on a scale Standard Deviation 17.71	27.45 units on a scale Standard Deviation 18.54	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Placebo of Focalin XR

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

10mg of Focalin XR

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

20 mg of Focalin XR

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

25/30mg of Focalin XR

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo of Adderall XR

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

10mg of Adderall XR

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

20 mg of Adderall XR

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

25/30mg of Adderall XR

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo of Focalin XR n=48 participants at risk Each participant recieved placebo of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.	10mg of Focalin XR n=53 participants at risk Each participant recieved 10 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.	20 mg of Focalin XR n=47 participants at risk Each participant recieved 20 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.	25/30mg of Focalin XR n=47 participants at risk Each participant recieved 25/30 mg (depending on weight) of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.	Placebo of Adderall XR n=54 participants at risk Each participant recieved placebo of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.	10mg of Adderall XR n=55 participants at risk Each participant recieved 10 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.	20 mg of Adderall XR n=52 participants at risk Each participant recieved 20 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.	25/30mg of Adderall XR n=51 participants at risk Each participant recieved 25/30 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
Nervous system disorders Seizure	0.00% 0/48 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/53 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	2.1% 1/47 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/54 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/55 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/52 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/51 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.

Other adverse events

Measure	Placebo of Focalin XR n=48 participants at risk Each participant recieved placebo of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.	10mg of Focalin XR n=53 participants at risk Each participant recieved 10 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.	20 mg of Focalin XR n=47 participants at risk Each participant recieved 20 mg of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.	25/30mg of Focalin XR n=47 participants at risk Each participant recieved 25/30 mg (depending on weight) of Focalin XR once during the first four weeks or last four weeks depending on the randomization schedule.	Placebo of Adderall XR n=54 participants at risk Each participant recieved placebo of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.	10mg of Adderall XR n=55 participants at risk Each participant recieved 10 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.	20 mg of Adderall XR n=52 participants at risk Each participant recieved 20 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.	25/30mg of Adderall XR n=51 participants at risk Each participant recieved 25/30 mg of Adderall XR once during the first four weeks or last four weeks depending on the randomization schedule.
General disorders Stares	0.00% 0/48 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/53 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/54 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.6% 2/55 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/52 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	2.0% 1/51 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
General disorders Uninterested	0.00% 0/48 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/53 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	2.1% 1/47 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	2.1% 1/47 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/54 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.6% 2/55 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/52 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	2.0% 1/51 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
General disorders Drowsiness	2.1% 1/48 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/53 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/54 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/55 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/52 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.9% 2/51 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
General disorders Sadness	0.00% 0/48 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.8% 2/53 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	2.1% 1/47 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/54 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/55 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/52 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.9% 2/51 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
General disorders Crying	2.1% 1/48 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/53 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	2.1% 1/47 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.7% 2/54 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.8% 1/55 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/52 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/51 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
Psychiatric disorders Anxiety	0.00% 0/48 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/53 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/54 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/55 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/52 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/51 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
General disorders Dizziness	0.00% 0/48 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/53 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/54 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/55 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/52 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	2.0% 1/51 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
General disorders Tics	0.00% 0/48 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/53 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/54 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/55 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/52 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/51 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
Psychiatric disorders Insomnia or trouble sleeping	4.2% 2/48 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.8% 2/53 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	10.6% 5/47 • Number of events 5 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	6.4% 3/47 • Number of events 3 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	5.6% 3/54 • Number of events 3 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	12.7% 7/55 • Number of events 7 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	11.5% 6/52 • Number of events 6 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	7.8% 4/51 • Number of events 4 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
General disorders Talk less	4.2% 2/48 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/53 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	4.3% 2/47 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	4.3% 2/47 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/54 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.8% 1/55 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/52 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	5.9% 3/51 • Number of events 3 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
Metabolism and nutrition disorders Loss of Appetite	2.1% 1/48 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	7.5% 4/53 • Number of events 4 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	12.8% 6/47 • Number of events 6 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	6.4% 3/47 • Number of events 3 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.7% 2/54 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	9.1% 5/55 • Number of events 5 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	13.5% 7/52 • Number of events 7 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	11.8% 6/51 • Number of events 6 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
General disorders Irritable	6.2% 3/48 • Number of events 3 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/53 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	14.9% 7/47 • Number of events 7 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	10.6% 5/47 • Number of events 5 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	5.6% 3/54 • Number of events 3 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	7.3% 4/55 • Number of events 4 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	9.6% 5/52 • Number of events 5 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	2.0% 1/51 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
Gastrointestinal disorders Stomach Ache	2.1% 1/48 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.8% 2/53 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	2.1% 1/47 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/54 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.8% 1/55 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/52 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	5.9% 3/51 • Number of events 3 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
General disorders Headache	0.00% 0/48 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.8% 2/53 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.7% 2/54 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.8% 1/55 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/52 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.9% 2/51 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
General disorders Nail biting	6.2% 3/48 • Number of events 3 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	13.2% 7/53 • Number of events 7 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	19.1% 9/47 • Number of events 9 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	12.8% 6/47 • Number of events 6 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	7.4% 4/54 • Number of events 4 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	16.4% 9/55 • Number of events 9 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	13.5% 7/52 • Number of events 7 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	9.8% 5/51 • Number of events 5 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
Psychiatric disorders Euphoric	4.2% 2/48 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/53 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.7% 2/54 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	3.6% 2/55 • Number of events 2 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/52 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/51 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.
General disorders Nightmare	0.00% 0/48 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/53 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/47 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	2.1% 1/47 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/54 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/55 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	1.9% 1/52 • Number of events 1 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.	0.00% 0/51 • 8-10 weeks. Adverse events were collected from participants while they were in the study, this time frame ranged from 8-10 weeks. At each weekly visit, children and their parents met with the investigators and research staff. Parents completed the Stimulant Side Effects Rating scale (SERS), a 17-item scale that is rated on a 10-point (0-9) scale ranging from absent to serious.

Additional Information

Dr. Mark Stein

Dept. of Psychiatry, University of Washington

Phone: 206-987-1161

Email: mstein42@uw.edu

Results disclosure agreements

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