Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Attention Deficit Hyperactivity Disorder, sleep, side effects, stimulants
Brief summary
The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications. This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood. It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
Detailed description
ADHD is often treated with stimulant medications, which have demonstrated short-term efficacy in numerous trials. However, treatment is often discontinued prematurely. Although ADHD often persists through adolescence, approximately half of all children who are treated with a stimulant medication discontinue treatment within one year (Charach, Ickowicz et al. 2004). Presumably, tolerability and treatment compliance are highly related to the side effect profile of stimulant medications (Schachar, Jadad et al. 2002). Sleep problems, particularly insomnia, are frequently associated with ADHD and are often exacerbated by stimulant medications, particularly at higher doses. Other frequent stimulant side effects are decreased appetite and mood lability (dysphoria/euphoria). Little is known about the relative effects of different stimulant formulations and dosages (i.e amphetamine, methylphenidate, dexmethylphenidate) on sleep and tolerability. There is some preliminary data with short acting stimulants suggesting a higher prevalence of sleep and appetite problems with amphetamine relative to mph (Pelham, Aronoff et al. 1999). Several studies indicate that sleep and other stimulant side effects are dose related (Stein, Sarampote et al. 2003), although this has not been found in all studies. Moreover, it is unclear if there are differences between long-acting amphetamine and methylphenidate based stimulants in their side effect profile and tolerability. Thus, we will directly compare these two long acting stimulant medications on their side effect profile and tolerability, including measures of sleep, mood, and evening behavior (e.g., family conflicts). The recently developed extended release formulation of dexmethylphenidate will be compared to one of the most common treatments for ADHD, extended release formulation of mixed amphetamine salts. The subject population will be older children and adolescents (10-17) with ADHD who are most likely to be treated with moderate to higher dose levels of stimulant medications and can complete all self-report measures.
Interventions
10, 20, 25-30 mg.
DRUGMixed Amphetamine Salts, ER
10, 20, 25-30
DRUGplacebo
randomized placebo week during each 4 week period
Sponsors
Novartis
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Any ADHD subtype, determined by KSADS interview (Kaufman, Birmaher et al. 1997). Comorbidity will likewise be allowed, to ensure representation. * Signed informed consent and assent * Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating is greater than or equal to 4 * Findings on physical exam, laboratory studies, vital signs, and ECG are judged to be normal for age * Pulse and blood pressure are within 95% of age and gender mean * Able to complete study instruments and swallow capsules * Willing to commit to the entire visit schedule for the study, including at least one visit to UIC Medical Center.
Exclusion criteria
* Previous diagnosis of mental retardation * Non-responder to either medication at the doses offered in the study in an adequate trial * Must not have experienced disabling adverse effects with either medication * Concomitant psychotropic medications are required or medications which might have a CNS effect * Any other medical condition which represents a contraindication for either treatment is present * History of alcohol or drug abuse in the past 3 months, or a positive urinary toxic screen on initial evaluation that is not explained by a time-limited medical circumstance * Females of childbearing age who are sexually active, do not use acceptable birth control (double protection method), and after counseling, are unwilling to do so * History of allergic reactions to multiple medications * A history of psychosis * Diagnosis of bipolar disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | 8-10 weeks | 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. |
| Sleep Duration | 8-10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADHD Parent Rating Scale-IV | 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. |
| Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | 8-10 weeks | 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. |
| Clinical Global Impression - Severity | 8-10 weeks | 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. |
| Weiss Functional Impairment Rating Scale (WFIRS) | 8-10 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Eligible participants were recruited from the investigators' practices, clinic referrals, and radio advertisements. Participants were enrolled between January 2007 and January 2009.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study 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 | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 0 | 1 |
| First Intervention | Lost to Follow-up | 3 | 3 |
| First Intervention | Protocol Violation | 1 | 0 |
| First Intervention | Withdrawal by Subject | 1 | 2 |
| Second Intervetion | Adverse Event | 0 | 3 |
| Second Intervetion | Lack of Efficacy | 1 | 0 |
| Second Intervetion | Lost to Follow-up | 0 | 2 |
| Second Intervetion | Protocol Violation | 1 | 1 |
| Second Intervetion | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Categorical <=18 years | 64 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 11.7 years STANDARD_DEVIATION 2.24 |
| Region of Enrollment United States | 64 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 48 | 23 / 53 | 32 / 47 | 22 / 47 | 23 / 54 | 35 / 55 | 29 / 52 | 31 / 51 |
| serious Total, serious adverse events | 0 / 48 | 0 / 53 | 1 / 47 | 0 / 47 | 0 / 54 | 0 / 55 | 0 / 52 | 0 / 51 |
Outcome results
Primary
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.
Time frame: 8-10 weeks
Population: participants with sufficient sleep actigraphy data for analysis (n=37)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Sleep Duration | 459.6 minutes | Standard Deviation 73.6 |
| 10mg of Either Focalin XR or Adderall XR | Sleep Duration | 446.7 minutes | Standard Deviation 63.58 |
| 20mg of Either Focalin XR or Adderall XR | Sleep Duration | 432.17 minutes | Standard Deviation 64.6 |
| 25/30mg of Either Focalin XR or Adderall XR | Sleep Duration | 425.5 minutes | Standard Deviation 61.5 |
| Adderall XR All Dose Levels | Sleep Duration | 438.82 minutes | Standard Deviation 67.2 |
| Focalin XR All Dose Levels | Sleep Duration | 443.2 minutes | Standard Deviation 66.9 |
Primary
Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep start time | 2249 HHMM.SS | Standard Deviation 12.19 |
| Placebo | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep End time | 0742 HHMM.SS | Standard Deviation 15.36 |
| 10mg of Either Focalin XR or Adderall XR | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep start time | 2304 HHMM.SS | Standard Deviation 10.4 |
| 10mg of Either Focalin XR or Adderall XR | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep End time | 0728 HHMM.SS | Standard Deviation 9.54 |
| 20mg of Either Focalin XR or Adderall XR | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep start time | 2319 HHMM.SS | Standard Deviation 12.21 |
| 20mg of Either Focalin XR or Adderall XR | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep End time | 0735 HHMM.SS | Standard Deviation 10.46 |
| 25/30mg of Either Focalin XR or Adderall XR | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep start time | 2325 HHMM.SS | Standard Deviation 11.17 |
| 25/30mg of Either Focalin XR or Adderall XR | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep End time | 0732 HHMM.SS | Standard Deviation 11.09 |
| Adderall XR All Dose Levels | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep start time | 2309 HHMM.SS | Standard Deviation 11.05 |
| Adderall XR All Dose Levels | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep End time | 0735 HHMM.SS | Standard Deviation 10.4 |
| Focalin XR All Dose Levels | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep start time | 2309 HHMM.SS | Standard Deviation 11.19 |
| Focalin XR All Dose Levels | Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. | Sleep End time | 0734 HHMM.SS | Standard Deviation 10.04 |
Secondary
ADHD Parent Rating Scale-IV
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.
Time frame: completed weekly over 8-10 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | ADHD Parent Rating Scale-IV | Hyperactivity/Impulsivity Symptom subscale scores | 11.41 units on a scale | Standard Deviation 8.55 |
| Placebo | ADHD Parent Rating Scale-IV | Total Symptoms scores | 28.02 units on a scale | Standard Deviation 15.15 |
| Placebo | ADHD Parent Rating Scale-IV | Inattention Symptom Subscale Scores | 16.61 units on a scale | Standard Deviation 7.8 |
| 10mg of Either Focalin XR or Adderall XR | ADHD Parent Rating Scale-IV | Total Symptoms scores | 27.15 units on a scale | Standard Deviation 14.49 |
| 10mg of Either Focalin XR or Adderall XR | ADHD Parent Rating Scale-IV | Inattention Symptom Subscale Scores | 6.40 units on a scale | Standard Deviation 8.55 |
| 10mg of Either Focalin XR or Adderall XR | ADHD Parent Rating Scale-IV | Hyperactivity/Impulsivity Symptom subscale scores | 10.78 units on a scale | Standard Deviation 7.6 |
| 20mg of Either Focalin XR or Adderall XR | ADHD Parent Rating Scale-IV | Inattention Symptom Subscale Scores | 12.2 units on a scale | Standard Deviation 8.08 |
| 20mg of Either Focalin XR or Adderall XR | ADHD Parent Rating Scale-IV | Total Symptoms scores | 20.12 units on a scale | Standard Deviation 13.87 |
| 20mg of Either Focalin XR or Adderall XR | ADHD Parent Rating Scale-IV | Hyperactivity/Impulsivity Symptom subscale scores | 7.92 units on a scale | Standard Deviation 6.78 |
| 25/30mg of Either Focalin XR or Adderall XR | ADHD Parent Rating Scale-IV | Total Symptoms scores | 20.40 units on a scale | Standard Deviation 13.68 |
| 25/30mg of Either Focalin XR or Adderall XR | ADHD Parent Rating Scale-IV | Inattention Symptom Subscale Scores | 12.74 units on a scale | Standard Deviation 8.38 |
| 25/30mg of Either Focalin XR or Adderall XR | ADHD Parent Rating Scale-IV | Hyperactivity/Impulsivity Symptom subscale scores | 7.67 units on a scale | Standard Deviation 6.62 |
| Adderall XR All Dose Levels | ADHD Parent Rating Scale-IV | Hyperactivity/Impulsivity Symptom subscale scores | 13.24 units on a scale | Standard Deviation 8.91 |
| Adderall XR All Dose Levels | ADHD Parent Rating Scale-IV | Inattention Symptom Subscale Scores | 17.31 units on a scale | Standard Deviation 8.23 |
| Adderall XR All Dose Levels | ADHD Parent Rating Scale-IV | Total Symptoms scores | 30.58 units on a scale | Standard Deviation 15.33 |
| Focalin XR All Dose Levels | ADHD Parent Rating Scale-IV | Hyperactivity/Impulsivity Symptom subscale scores | 10.84 units on a scale | Standard Deviation 7.37 |
| Focalin XR All Dose Levels | ADHD Parent Rating Scale-IV | Inattention Symptom Subscale Scores | 17.51 units on a scale | Standard Deviation 7.03 |
| Focalin XR All Dose Levels | ADHD Parent Rating Scale-IV | Total Symptoms scores | 28.35 units on a scale | Standard Deviation 12.74 |
| Focalin XR - 20 mg | ADHD Parent Rating Scale-IV | Hyperactivity/Impulsivity Symptom subscale scores | 8.49 units on a scale | Standard Deviation 7.37 |
| Focalin XR - 20 mg | ADHD Parent Rating Scale-IV | Inattention Symptom Subscale Scores | 13.33 units on a scale | Standard Deviation 7.08 |
| Focalin XR - 20 mg | ADHD Parent Rating Scale-IV | Total Symptoms scores | 21.82 units on a scale | Standard Deviation 12.72 |
| Focalin XR - 25/30mg | ADHD Parent Rating Scale-IV | Inattention Symptom Subscale Scores | 12.11 units on a scale | Standard Deviation 8.72 |
| Focalin XR - 25/30mg | ADHD Parent Rating Scale-IV | Hyperactivity/Impulsivity Symptom subscale scores | 8.49 units on a scale | Standard Deviation 6.7 |
| Focalin XR - 25/30mg | ADHD Parent Rating Scale-IV | Total Symptoms scores | 20.41 units on a scale | Standard Deviation 13.61 |
Secondary
Clinical Global Impression - Severity
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Clinical Global Impression - Severity | 4.26 units on a scale | Standard Deviation 1.18 |
| 10mg of Either Focalin XR or Adderall XR | Clinical Global Impression - Severity | 4.09 units on a scale | Standard Deviation 1.29 |
| 20mg of Either Focalin XR or Adderall XR | Clinical Global Impression - Severity | 3.48 units on a scale | Standard Deviation 1.34 |
| 25/30mg of Either Focalin XR or Adderall XR | Clinical Global Impression - Severity | 3.56 units on a scale | Standard Deviation 1.27 |
| Adderall XR All Dose Levels | Clinical Global Impression - Severity | 4.24 units on a scale | Standard Deviation 1.13 |
| Focalin XR All Dose Levels | Clinical Global Impression - Severity | 4.24 units on a scale | Standard Deviation 0.76 |
| Focalin XR - 20 mg | Clinical Global Impression - Severity | 3.63 units on a scale | Standard Deviation 1.2 |
| Focalin XR - 25/30mg | Clinical Global Impression - Severity | 3.55 units on a scale | Standard Deviation 1.35 |
Secondary
Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.40 units on a scale | Standard Deviation 0.55 |
| Placebo | 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 |
| Placebo | 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 8.9 |
| Placebo | 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 |
| 10mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.33 units on a scale | Standard Deviation 1.51 |
| 10mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 18.33 units on a scale | Standard Deviation 10.03 |
| 10mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 37.17 units on a scale | Standard Deviation 20.55 |
| 10mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 18.83 units on a scale | Standard Deviation 10.59 |
| 20mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.80 units on a scale | Standard Deviation 1.3 |
| 20mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 33.80 units on a scale | Standard Deviation 16.33 |
| 20mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 14.80 units on a scale | Standard Deviation 8.07 |
| 20mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 19.00 units on a scale | Standard Deviation 8.51 |
| 25/30mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 15.40 units on a scale | Standard Deviation 9.18 |
| 25/30mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 10.40 units on a scale | Standard Deviation 9.96 |
| 25/30mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.00 units on a scale | Standard Deviation 1.58 |
| 25/30mg of Either Focalin XR or Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 25.80 units on a scale | Standard Deviation 19.03 |
| Adderall XR All Dose Levels | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 17.33 units on a scale | Standard Deviation 2.52 |
| Adderall XR All Dose Levels | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 19.33 units on a scale | Standard Deviation 7.51 |
| Adderall XR All Dose Levels | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 36.67 units on a scale | Standard Deviation 6.43 |
| Adderall XR All Dose Levels | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.67 units on a scale | Standard Deviation 0.58 |
| Focalin XR All Dose Levels | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 39.60 units on a scale | Standard Deviation 8.44 |
| Focalin XR All Dose Levels | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 17.40 units on a scale | Standard Deviation 4.77 |
| Focalin XR All Dose Levels | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 22.20 units on a scale | Standard Deviation 4.76 |
| Focalin XR All Dose Levels | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.60 units on a scale | Standard Deviation 0.55 |
| Focalin XR - 20 mg | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 14.00 units on a scale | Standard Deviation 9.13 |
| Focalin XR - 20 mg | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 16.75 units on a scale | Standard Deviation 8.81 |
| Focalin XR - 20 mg | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.50 units on a scale | Standard Deviation 1.29 |
| Focalin XR - 20 mg | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 30.75 units on a scale | Standard Deviation 17.63 |
| Focalin XR - 25/30mg | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.00 units on a scale | Standard Deviation 1.63 |
| Focalin XR - 25/30mg | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 24.00 units on a scale | Standard Deviation 17.19 |
| Focalin XR - 25/30mg | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 12.50 units on a scale | Standard Deviation 9.81 |
| Focalin XR - 25/30mg | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 9.00 units on a scale | Standard Deviation 7.07 |
| 9/10 Allele: Placebo of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.36 units on a scale | Standard Deviation 1.08 |
| 9/10 Allele: Placebo of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 9.36 units on a scale | Standard Deviation 8.95 |
| 9/10 Allele: Placebo of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 28.00 units on a scale | Standard Deviation 13.59 |
| 9/10 Allele: Placebo of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 18.64 units on a scale | Standard Deviation 6.55 |
| 9/10 Allele: 10 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 16.27 units on a scale | Standard Deviation 7.33 |
| 9/10 Allele: 10 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 26.80 units on a scale | Standard Deviation 13.14 |
| 9/10 Allele: 10 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.07 units on a scale | Standard Deviation 1.03 |
| 9/10 Allele: 10 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 10.67 units on a scale | Standard Deviation 7.74 |
| 9/10 Allele: 20 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 24.21 units on a scale | Standard Deviation 13.01 |
| 9/10 Allele: 20 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 8.36 units on a scale | Standard Deviation 7.04 |
| 9/10 Allele: 20 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 15.86 units on a scale | Standard Deviation 6.71 |
| 9/10 Allele: 20 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 3.71 units on a scale | Standard Deviation 1.14 |
| 9/10 Allele: 25/30 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 6.43 units on a scale | Standard Deviation 6.95 |
| 9/10 Allele: 25/30 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 13.43 units on a scale | Standard Deviation 7.95 |
| 9/10 Allele: 25/30 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 19.86 units on a scale | Standard Deviation 12.84 |
| 9/10 Allele: 25/30 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 3.50 units on a scale | Standard Deviation 1.4 |
| 9/10 Allele: Placebo of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 27.08 units on a scale | Standard Deviation 15.71 |
| 9/10 Allele: Placebo of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 18.08 units on a scale | Standard Deviation 8.51 |
| 9/10 Allele: Placebo of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 8.92 units on a scale | Standard Deviation 9.38 |
| 9/10 Allele: Placebo of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.31 units on a scale | Standard Deviation 0.95 |
| 9/10 Allele: 10 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 25.20 units on a scale | Standard Deviation 11.89 |
| 9/10 Allele: 10 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 16.93 units on a scale | Standard Deviation 5.59 |
| 9/10 Allele: 10 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.27 units on a scale | Standard Deviation 0.7 |
| 9/10 Allele: 10 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 8.27 units on a scale | Standard Deviation 7.23 |
| 9/10 Allele: 20 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 20.09 units on a scale | Standard Deviation 13.71 |
| 9/10 Allele: 20 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 6.73 units on a scale | Standard Deviation 7.04 |
| 9/10 Allele: 20 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 3.58 units on a scale | Standard Deviation 1.38 |
| 9/10 Allele: 20 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 13.36 units on a scale | Standard Deviation 8.27 |
| 9/10 Allele: 25/30 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 7.00 units on a scale | Standard Deviation 7.02 |
| 9/10 Allele: 25/30 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 13.70 units on a scale | Standard Deviation 9.86 |
| 9/10 Allele: 25/30 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 3.90 units on a scale | Standard Deviation 1.66 |
| 9/10 Allele: 25/30 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 20.70 units on a scale | Standard Deviation 15.84 |
| 10/10 Allele: Placebo of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.17 units on a scale | Standard Deviation 1.39 |
| 10/10 Allele: Placebo of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 26.93 units on a scale | Standard Deviation 16.05 |
| 10/10 Allele: Placebo of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 15.07 units on a scale | Standard Deviation 8.14 |
| 10/10 Allele: Placebo of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 11.87 units on a scale | Standard Deviation 8.76 |
| 10/10 Allele: 10 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 16.13 units on a scale | Standard Deviation 9.35 |
| 10/10 Allele: 10 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 9.63 units on a scale | Standard Deviation 6.83 |
| 10/10 Allele: 10 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.07 units on a scale | Standard Deviation 1.48 |
| 10/10 Allele: 10 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 25.77 units on a scale | Standard Deviation 14.33 |
| 10/10 Allele: 20 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 3.21 units on a scale | Standard Deviation 1.32 |
| 10/10 Allele: 20 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 7.07 units on a scale | Standard Deviation 6.18 |
| 10/10 Allele: 20 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 16.43 units on a scale | Standard Deviation 13.01 |
| 10/10 Allele: 20 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 9.36 units on a scale | Standard Deviation 7.88 |
| 10/10 Allele: 25/30 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 19.46 units on a scale | Standard Deviation 13.2 |
| 10/10 Allele: 25/30 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 11.96 units on a scale | Standard Deviation 8.65 |
| 10/10 Allele: 25/30 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 3.54 units on a scale | Standard Deviation 1.24 |
| 10/10 Allele: 25/30 mg of Adderall XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 7.50 units on a scale | Standard Deviation 5.7 |
| 10/10 Allele: Placebo of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 16.44 units on a scale | Standard Deviation 8.44 |
| 10/10 Allele: Placebo of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 30.19 units on a scale | Standard Deviation 16.49 |
| 10/10 Allele: Placebo of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 13.74 units on a scale | Standard Deviation 9.19 |
| 10/10 Allele: Placebo of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.15 units on a scale | Standard Deviation 1.29 |
| 10/10 Allele: 10 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 27.19 units on a scale | Standard Deviation 12.93 |
| 10/10 Allele: 10 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 10.63 units on a scale | Standard Deviation 7.14 |
| 10/10 Allele: 10 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 16.56 units on a scale | Standard Deviation 7.92 |
| 10/10 Allele: 10 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 4.19 units on a scale | Standard Deviation 0.83 |
| 10/10 Allele: 20 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 8.41 units on a scale | Standard Deviation 6.34 |
| 10/10 Allele: 20 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 12.56 units on a scale | Standard Deviation 6.64 |
| 10/10 Allele: 20 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 3.52 units on a scale | Standard Deviation 1.12 |
| 10/10 Allele: 20 mg of Focalin XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 20.96 units on a scale | Standard Deviation 11.98 |
| 10/10 Allele: 25/30mg of Focaling XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | CGI-S score | 3.31 units on a scale | Standard Deviation 1.26 |
| 10/10 Allele: 25/30mg of Focaling XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS total score | 19.81 units on a scale | Standard Deviation 13.26 |
| 10/10 Allele: 25/30mg of Focaling XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Inattention subscale score | 11.15 units on a scale | Standard Deviation 8.61 |
| 10/10 Allele: 25/30mg of Focaling XR | Dopamine Active Transporter (DAT) 1 Gene Type Effects on ADHD Symptoms | ADHD-RS Hyperactivity/Impulsivity subscale score | 8.65 units on a scale | Standard Deviation 6.46 |
Secondary
Weiss Functional Impairment Rating Scale (WFIRS)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Weiss Functional Impairment Rating Scale (WFIRS) | Social activities subscale score | 3.51 units on a scale | Standard Deviation 3.53 |
| Placebo | Weiss Functional Impairment Rating Scale (WFIRS) | Risky activities subscale score | 2.19 units on a scale | Standard Deviation 2.56 |
| Placebo | Weiss Functional Impairment Rating Scale (WFIRS) | Life skills subscale score | 7.43 units on a scale | Standard Deviation 4.32 |
| Placebo | Weiss Functional Impairment Rating Scale (WFIRS) | Family subscale score | 6.72 units on a scale | Standard Deviation 6.13 |
| Placebo | Weiss Functional Impairment Rating Scale (WFIRS) | Learning subscale score | 6.74 units on a scale | Standard Deviation 5.63 |
| Placebo | Weiss Functional Impairment Rating Scale (WFIRS) | Self-concept subscale score | 1.11 units on a scale | Standard Deviation 1.46 |
| Placebo | Weiss Functional Impairment Rating Scale (WFIRS) | Total score | 27.70 units on a scale | Standard Deviation 17.03 |
| 10mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Total score | 31.06 units on a scale | Standard Deviation 18.93 |
| 10mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Social activities subscale score | 3.91 units on a scale | Standard Deviation 3.81 |
| 10mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Learning subscale score | 8.75 units on a scale | Standard Deviation 6.7 |
| 10mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Life skills subscale score | 7.91 units on a scale | Standard Deviation 4.78 |
| 10mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Self-concept subscale score | 1.59 units on a scale | Standard Deviation 2.05 |
| 10mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Family subscale score | 7.02 units on a scale | Standard Deviation 6.41 |
| 10mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Risky activities subscale score | 1.94 units on a scale | Standard Deviation 2.3 |
| 20mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Social activities subscale score | 2.98 units on a scale | Standard Deviation 3.1 |
| 20mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Total score | 27.32 units on a scale | Standard Deviation 19.53 |
| 20mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Self-concept subscale score | 1.42 units on a scale | Standard Deviation 1.8 |
| 20mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Learning subscale score | 6.86 units on a scale | Standard Deviation 6.19 |
| 20mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Family subscale score | 6.35 units on a scale | Standard Deviation 6.1 |
| 20mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Risky activities subscale score | 2.24 units on a scale | Standard Deviation 3.41 |
| 20mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Life skills subscale score | 7.44 units on a scale | Standard Deviation 4.99 |
| 25/30mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Self-concept subscale score | 1.06 units on a scale | Standard Deviation 1.61 |
| 25/30mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Total score | 26.23 units on a scale | Standard Deviation 19.74 |
| 25/30mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Learning subscale score | 6.21 units on a scale | Standard Deviation 5.62 |
| 25/30mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Risky activities subscale score | 1.68 units on a scale | Standard Deviation 2.23 |
| 25/30mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Life skills subscale score | 7.34 units on a scale | Standard Deviation 4.45 |
| 25/30mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Family subscale score | 6.70 units on a scale | Standard Deviation 7.14 |
| 25/30mg of Either Focalin XR or Adderall XR | Weiss Functional Impairment Rating Scale (WFIRS) | Social activities subscale score | 3.06 units on a scale | Standard Deviation 4.05 |
| Adderall XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Self-concept subscale score | 1.25 units on a scale | Standard Deviation 1.97 |
| Adderall XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Family subscale score | 7.39 units on a scale | Standard Deviation 7.14 |
| Adderall XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Learning subscale score | 9.30 units on a scale | Standard Deviation 6.34 |
| Adderall XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Life skills subscale score | 8.30 units on a scale | Standard Deviation 4.76 |
| Adderall XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Social activities subscale score | 3.73 units on a scale | Standard Deviation 4.14 |
| Adderall XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Risky activities subscale score | 1.91 units on a scale | Standard Deviation 1.64 |
| Adderall XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Total score | 20.91 units on a scale | Standard Deviation 17.5 |
| Focalin XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Self-concept subscale score | 1.19 units on a scale | Standard Deviation 1.47 |
| Focalin XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Total score | 31.13 units on a scale | Standard Deviation 17.11 |
| Focalin XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Social activities subscale score | 3.85 units on a scale | Standard Deviation 3.57 |
| Focalin XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Life skills subscale score | 7.65 units on a scale | Standard Deviation 4.44 |
| Focalin XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Risky activities subscale score | 1.96 units on a scale | Standard Deviation 2.12 |
| Focalin XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Learning subscale score | 9.25 units on a scale | Standard Deviation 5.94 |
| Focalin XR All Dose Levels | Weiss Functional Impairment Rating Scale (WFIRS) | Family subscale score | 7.35 units on a scale | Standard Deviation 6.09 |
| Focalin XR - 20 mg | Weiss Functional Impairment Rating Scale (WFIRS) | Learning subscale score | 7.54 units on a scale | Standard Deviation 5.24 |
| Focalin XR - 20 mg | Weiss Functional Impairment Rating Scale (WFIRS) | Family subscale score | 6.50 units on a scale | Standard Deviation 6.42 |
| Focalin XR - 20 mg | Weiss Functional Impairment Rating Scale (WFIRS) | Risky activities subscale score | 1.78 units on a scale | Standard Deviation 1.78 |
| Focalin XR - 20 mg | Weiss Functional Impairment Rating Scale (WFIRS) | Social activities subscale score | 3.54 units on a scale | Standard Deviation 3.4 |
| Focalin XR - 20 mg | Weiss Functional Impairment Rating Scale (WFIRS) | Total score | 29.20 units on a scale | Standard Deviation 17.71 |
| Focalin XR - 20 mg | Weiss Functional Impairment Rating Scale (WFIRS) | Life skills subscale score | 8.30 units on a scale | Standard Deviation 5.48 |
| Focalin XR - 20 mg | Weiss Functional Impairment Rating Scale (WFIRS) | Self-concept subscale score | 1.33 units on a scale | Standard Deviation 1.61 |
| Focalin XR - 25/30mg | Weiss Functional Impairment Rating Scale (WFIRS) | Total score | 27.45 units on a scale | Standard Deviation 18.54 |
| Focalin XR - 25/30mg | Weiss Functional Impairment Rating Scale (WFIRS) | Self-concept subscale score | 1.31 units on a scale | Standard Deviation 1.97 |
| Focalin XR - 25/30mg | Weiss Functional Impairment Rating Scale (WFIRS) | Risky activities subscale score | 1.67 units on a scale | Standard Deviation 1.73 |
| Focalin XR - 25/30mg | Weiss Functional Impairment Rating Scale (WFIRS) | Family subscale score | 6.50 units on a scale | Standard Deviation 6.46 |
| Focalin XR - 25/30mg | Weiss Functional Impairment Rating Scale (WFIRS) | Life skills subscale score | 7.60 units on a scale | Standard Deviation 5.66 |
| Focalin XR - 25/30mg | Weiss Functional Impairment Rating Scale (WFIRS) | Social activities subscale score | 3.17 units on a scale | Standard Deviation 3.98 |
| Focalin XR - 25/30mg | Weiss Functional Impairment Rating Scale (WFIRS) | Learning subscale score | 7.39 units on a scale | Standard Deviation 5.78 |