Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
ADHD, Child, Adolescent, School
Brief summary
This study will determine the effectiveness of stimulant and nonstimulant medication in treating the symptoms of attention deficit hyperactivity disorder (ADHD) in children and adolescents.
Detailed description
ADHD is one of the most frequently occurring disorders of children and adolescents and is a significant public health problem. The most common treatment for the condition is stimulant medication. However, there are an increasing number of children who are experiencing negative side effects from stimulants, such as dizziness, loss of appetite, and headaches; these side effects have made the need for alternative treatments all the more important. This study will compare the stimulant methylphenidate to the nonstimulant atomoxetine to determine which is more effective in treating ADHD symptoms in children and adolescents. The two medications differ in the neurotransmitters they influence. Stimulants such as methylphenidate act upon the neurotransmitter dopamine, while atomoxetine works on norepinephrine. It has been proposed that the difference in neurotransmitter stimulation may result in differences in an ADHD patient's response to treatment. Participants will be randomly assigned to receive either methylphenidate or atomoxetine for between 4 to 6 weeks, depending on how soon they respond to the treatment. After the 4 to 6 week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study. Participants will have up to 14 weekly study visits. Over the first two visits, participants will undergo psychological and intelligence tests, a medical history, an electrocardiogram, blood and urine collection, and a physical exam. The remaining visits will occur weekly. During these visits, participants will receive their assigned medication and, along with their parents, will complete questionnaires about their response to treatment and any side effects they may be experiencing. The teachers of all participants will be asked to complete a questionnaire about their student's behavior at 4 different times during the study. Participant, parent, and teacher questionnaires will be used to assess the ADHD symptoms of participants, as well as self-report clinical scales completed by the participants.
Interventions
DRUGAtomoxetine
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
DRUGMethylphenidate
Participants will be randomly assigned to receive either methylphenidate or atomoxetine for either 2 or 5 weeks, depending on how soon they respond to the treatment. After the 2- or 5-week period, participants will be crossed-over to receive whichever medication they did not receive in the first part of the study.
Sponsors
National Institute of Mental Health (NIMH)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Meets DSM-IV-TR criteria for ADHD * Scores at least 1.5 standard deviation higher than age and gender mean on ADHD-RS keyed to ADHD subtype * CGI Severity ADHD Rating greater than or equal to 4 * Currently attends school with at least 3 months left in high school * Currently lives at home with parent(s) or legal guardian(s), now and for the past year before study entry, and is expected to remain there * Normal physical exam, laboratory tests, and electrocardiogram * Pulse and blood pressure within 95% of age and gender mean * Full Scale IQ is greater than or equal to 75 OR if the results of testing indicate that Full Scale IQ is not a good indicator of intellectual ability, a General Ability Index greater than or equal to 75 * Weight is between 20 and 85 kilograms * Able to swallow pills * Parent or guardian willing to provide informed consent
Exclusion criteria
* History of atomoxetine or methylphenidate intolerance * Any existing medical condition for which study medications are contraindicated * If the child is in psychotherapy, no changes in therapy expected during the study trial * Presence of any of the following: autism, mental retardation, schizophrenia, a psychotic disorder, bipolar disorder, severe depression, or conduct disorder * Presence of a comorbid disorder that should be the primary focus of treatment * Presence of a medical or neurological disorder precluding study medications or assessing ADHD * Allergic reactions to multiple medications * History of alcohol or drug abuse in the 3 months before study entry, or positive urine toxic screen that is not explained by a time limited medical circumstance * Involved in a medication treatment study in the 30 days before study entry * Female who is sexually active and is unwilling to use birth control * Evidence of child abuse or neglect
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ADHD-RS Total Score | up to 14 weeks | ADHD-RS Total Score Attention Deficit Hyperactivity Disorder Rating Scale. Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. Higher score indicates higher probability of diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADHD - H/I | up to 14 weeks | Attention deficit/hyperactivity disorder - hyperactivity/impulsivity (ADHD- H/I). Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis. |
| ADHD-RS Inattention | up to 14 weeks | Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis. |
| Clinical Global Impressions (CGI)- Severity | up to 14 weeks | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. |
| Social Skills Rating Scale (SSRS)- Parent Version | up to 14 weeks | Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available. |
| Child Conflict Index (CCI) | up to 14 weeks | Measure of conflict within the home over the past 24 hours. The CCI is a validated measure of family conflicts in the home and is completed by parents. It consists of 42 items (for boys) or 36 items (for girls) reflecting attention-seeking and conflictual behavior, as well as negativity and withdrawal. Items are scored as yes (1 point) or no (0 points). Mean score between 0 and 1 reported, with higher score indicating greater conflict. |
| Continuous Performance Test (CPT) | up to 14 weeks | CPT Commissions, impulsive responses, higher score is worse. This scale is based on t-scores and does not have psychometrics available. |
| Children's Sleep Questionnaire | up to 14 weeks | Children's Sleep Problems Severity, sum of scores, higher is worse.The scale assessed contains 16 items, each scored 0 to 3, with 0 representing no problems and 3 representing daily problems. total range from 0 to 48. This score does not have psychometrics available. |
| Assessment of Affective Range (AAR) | up to 14 weeks | Affective problems. This scale consists of 8 items, scored 0-3, with 0 representing no problems and 3 representing extreme problems. This analysis presents sum of scores, higher is worse. Full range from 0 to 24. This score does not have psychometrics available. |
| Tics: Total Motor | up to 14 weeks | Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50). |
| Tics: Total Phonic | up to 14 weeks | Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50). |
| Tics: Total Impairment | up to 14 weeks | Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50). |
| Vital Signs - Systolic Blood Pressure | up to 14 weeks | Systolic blood pressure - the amount of pressure in arteries during contraction of the heart muscle Normal range varies by age, sex, height and weight and can range from 80mm Hg to 130mmHg |
| Treatment Preference Survey | Measured at ends of treatments one and two | — |
| Vital Signs - Pulse | up to 14 weeks | Heartbeats per minute. Range varies from 50-205 depending on age and level of activity. |
| SES (Hollingshead) | up to 14 weeks | Measure of socioeconomic status, score calculated from averaging likert responses, lower = worse |
| Conners-Wells Adolescent Self Report | up to 14 weeks | Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse |
| Conners Teacher Rating Scale- Short | up to 14 weeks | Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse |
| Child Behavior Checklist (CBCL) | Measured at screening | CBCL Total Score, measure of psychosocial problems, higher is worse. |
| Social Skills Rating Scale (SSRS)- Teacher Version | up to 14 weeks | Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available. |
| Permanent Mathematics Product Test (PERMP) | up to 14 weeks | Measure of fluency in performance of simple mathematics, sum, lower = worse |
| Actigraphy | Measured daily throughout the study | Measure of physical activity |
| Sleep Logs | Measured daily throughout the study | Questionnaire, qualitative |
| Hyperactivity, Attention, and Learning Problems (HALP) Medical and Developmental History Questionnaire | Measured at screening | Questionnaire, qualitative designed to collect family history, prenatal environmental influences, and developmental history. |
| HALP Rebound Effects Questionnaire | up to 14 weeks | Questionnaire, qualitative assesses symptoms of rebound (moodiness, irritability, aggression, and ADHD symptoms) when the medication wears off at night. |
| Vital Signs - Diastolic Blood Pressure | up to 14 weeks | Diastole blood pressure - blood pressure when the heart muscle is between beats. normal range varies by age, sex, height and weight and can range from 34mm Hg to 90mmHg |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atomoxetine Then Methylphenidate Participants randomized to receive Atomoxetine until optimal response, then washed out and crossed-over to receive Methylphenidate. | 108 |
| Methylphenidate Then Atomoxetine Participants randomized to receive Methylphenidate until optimal response, then washed out and crossed-over to receive Atomoxetine. | 124 |
| Total | 232 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Block 1 - 5 Weeks | Withdrawal by Subject | 13 | 14 |
| Block 2 - 5 Weeks | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Atomoxetine Then Methylphenidate | Methylphenidate Then Atomoxetine | Total |
|---|---|---|---|
| Age, Continuous | 10.34 years STANDARD_DEVIATION 2.61 | 10.56 years STANDARD_DEVIATION 2.83 | 10.41 years STANDARD_DEVIATION 2.72 |
| Sex: Female, Male Female | 27 Participants | 36 Participants | 63 Participants |
| Sex: Female, Male Male | 81 Participants | 88 Participants | 169 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 108 | 0 / 124 | 0 / 95 | 0 / 110 |
| other Total, other adverse events | 24 / 108 | 35 / 124 | 20 / 95 | 25 / 110 |
| serious Total, serious adverse events | 0 / 108 | 0 / 124 | 0 / 95 | 0 / 110 |
Outcome results
Primary
ADHD-RS Total Score
ADHD-RS Total Score Attention Deficit Hyperactivity Disorder Rating Scale. Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. Higher score indicates higher probability of diagnosis.
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | ADHD-RS Total Score | Block 1 Baseline Week 0 | 39.58 units on a scale | Standard Deviation 8.984 |
| Atomoxetine Then Methylphenidate | ADHD-RS Total Score | Block 1 End of Treatment Week 6 | 20.03 units on a scale | Standard Deviation 13.657 |
| Atomoxetine Then Methylphenidate | ADHD-RS Total Score | Block 2 Baseline Week 8 | 34.32 units on a scale | Standard Deviation 11.423 |
| Atomoxetine Then Methylphenidate | ADHD-RS Total Score | Blocks 2 End of Treatment Week 14 | 18.08 units on a scale | Standard Deviation 12.192 |
| Methylphenidate Then Atomoxetine | ADHD-RS Total Score | Blocks 2 End of Treatment Week 14 | 22.13 units on a scale | Standard Deviation 13.356 |
| Methylphenidate Then Atomoxetine | ADHD-RS Total Score | Block 1 Baseline Week 0 | 39.75 units on a scale | Standard Deviation 9.835 |
| Methylphenidate Then Atomoxetine | ADHD-RS Total Score | Block 2 Baseline Week 8 | 33.54 units on a scale | Standard Deviation 12.077 |
| Methylphenidate Then Atomoxetine | ADHD-RS Total Score | Block 1 End of Treatment Week 6 | 17.59 units on a scale | Standard Deviation 12.756 |
Secondary
Actigraphy
Measure of physical activity
Time frame: Measured daily throughout the study
Population: data not collected
Secondary
ADHD - H/I
Attention deficit/hyperactivity disorder - hyperactivity/impulsivity (ADHD- H/I). Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis.
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | ADHD - H/I | Block 2 Baseline 8 | 13.99 units on a scale | Standard Deviation 8.258 |
| Atomoxetine Then Methylphenidate | ADHD - H/I | Block 1 End of Treatment Week 6 | 7.82 units on a scale | Standard Deviation 7.159 |
| Atomoxetine Then Methylphenidate | ADHD - H/I | Blocks 2 End of Treatment Week 14 | 6.67 units on a scale | Standard Deviation 5.818 |
| Atomoxetine Then Methylphenidate | ADHD - H/I | Block 1 Baseline Week 0 | 16.56 units on a scale | Standard Deviation 7.235 |
| Methylphenidate Then Atomoxetine | ADHD - H/I | Blocks 2 End of Treatment Week 14 | 8.87 units on a scale | Standard Deviation 7.651 |
| Methylphenidate Then Atomoxetine | ADHD - H/I | Block 1 End of Treatment Week 6 | 7.24 units on a scale | Standard Deviation 7.083 |
| Methylphenidate Then Atomoxetine | ADHD - H/I | Block 2 Baseline 8 | 14.80 units on a scale | Standard Deviation 8.31 |
| Methylphenidate Then Atomoxetine | ADHD - H/I | Block 1 Baseline Week 0 | 17.31 units on a scale | Standard Deviation 7.887 |
Secondary
ADHD-RS Inattention
Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-27. Higher score indicates higher probability of diagnosis.
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | ADHD-RS Inattention | Blocks 2 End of Treatment Week 14 | 11.09 units on a scale | Standard Deviation 7.103 |
| Atomoxetine Then Methylphenidate | ADHD-RS Inattention | Block 1 Baseline Week 0 | 23.30 units on a scale | Standard Deviation 3.524 |
| Atomoxetine Then Methylphenidate | ADHD-RS Inattention | Block 1 End of Treatment Week 6 | 12.32 units on a scale | Standard Deviation 7.889 |
| Atomoxetine Then Methylphenidate | ADHD-RS Inattention | Block 2 Baseline Week 8 | 20.33 units on a scale | Standard Deviation 5.525 |
| Methylphenidate Then Atomoxetine | ADHD-RS Inattention | Block 2 Baseline Week 8 | 18.74 units on a scale | Standard Deviation 5.572 |
| Methylphenidate Then Atomoxetine | ADHD-RS Inattention | Blocks 2 End of Treatment Week 14 | 13.26 units on a scale | Standard Deviation 7.398 |
| Methylphenidate Then Atomoxetine | ADHD-RS Inattention | Block 1 End of Treatment Week 6 | 10.35 units on a scale | Standard Deviation 7.172 |
| Methylphenidate Then Atomoxetine | ADHD-RS Inattention | Block 1 Baseline Week 0 | 22.44 units on a scale | Standard Deviation 4.027 |
Secondary
Assessment of Affective Range (AAR)
Affective problems. This scale consists of 8 items, scored 0-3, with 0 representing no problems and 3 representing extreme problems. This analysis presents sum of scores, higher is worse. Full range from 0 to 24. This score does not have psychometrics available.
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Assessment of Affective Range (AAR) | Block 1 Baseline Week 0 | 11.2609 units on a scale | Standard Deviation 2.85251 |
| Atomoxetine Then Methylphenidate | Assessment of Affective Range (AAR) | Block 2 Baseline Week 8 | 9.7108 units on a scale | Standard Deviation 2.99402 |
| Atomoxetine Then Methylphenidate | Assessment of Affective Range (AAR) | Block 1 End of Treatment Week 6 | 10.6889 units on a scale | Standard Deviation 2.83495 |
| Atomoxetine Then Methylphenidate | Assessment of Affective Range (AAR) | Blocks 2 End of Treatment Week 14 | 10.9886 units on a scale | Standard Deviation 2.69736 |
| Methylphenidate Then Atomoxetine | Assessment of Affective Range (AAR) | Block 1 End of Treatment Week 6 | 10.8257 units on a scale | Standard Deviation 2.7717 |
| Methylphenidate Then Atomoxetine | Assessment of Affective Range (AAR) | Block 1 Baseline Week 0 | 10.6905 units on a scale | Standard Deviation 3.44309 |
| Methylphenidate Then Atomoxetine | Assessment of Affective Range (AAR) | Blocks 2 End of Treatment Week 14 | 10.9286 units on a scale | Standard Deviation 3.02652 |
| Methylphenidate Then Atomoxetine | Assessment of Affective Range (AAR) | Block 2 Baseline Week 8 | 10.1400 units on a scale | Standard Deviation 3.06831 |
Secondary
Child Behavior Checklist (CBCL)
CBCL Total Score, measure of psychosocial problems, higher is worse.
Time frame: Measured at screening
Population: data not collected
Secondary
Child Conflict Index (CCI)
Measure of conflict within the home over the past 24 hours. The CCI is a validated measure of family conflicts in the home and is completed by parents. It consists of 42 items (for boys) or 36 items (for girls) reflecting attention-seeking and conflictual behavior, as well as negativity and withdrawal. Items are scored as yes (1 point) or no (0 points). Mean score between 0 and 1 reported, with higher score indicating greater conflict.
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Child Conflict Index (CCI) | Block 1 Baseline Week 0 | .3224 units on a scale | Standard Deviation 0.19841 |
| Atomoxetine Then Methylphenidate | Child Conflict Index (CCI) | Block 1 End of Treatment week 6 | .2386 units on a scale | Standard Deviation 0.21233 |
| Atomoxetine Then Methylphenidate | Child Conflict Index (CCI) | Block 1 End of Treatment Week 8 | .3526 units on a scale | Standard Deviation 0.20878 |
| Atomoxetine Then Methylphenidate | Child Conflict Index (CCI) | Blocks 2 End of Treatment Week 14 | .2118 units on a scale | Standard Deviation 0.20053 |
| Methylphenidate Then Atomoxetine | Child Conflict Index (CCI) | Blocks 2 End of Treatment Week 14 | .2304 units on a scale | Standard Deviation 0.18978 |
| Methylphenidate Then Atomoxetine | Child Conflict Index (CCI) | Block 1 Baseline Week 0 | .3385 units on a scale | Standard Deviation 0.19795 |
| Methylphenidate Then Atomoxetine | Child Conflict Index (CCI) | Block 1 End of Treatment Week 8 | .3078 units on a scale | Standard Deviation 0.20744 |
| Methylphenidate Then Atomoxetine | Child Conflict Index (CCI) | Block 1 End of Treatment week 6 | .1978 units on a scale | Standard Deviation 0.20251 |
Secondary
Children's Sleep Questionnaire
Children's Sleep Problems Severity, sum of scores, higher is worse.The scale assessed contains 16 items, each scored 0 to 3, with 0 representing no problems and 3 representing daily problems. total range from 0 to 48. This score does not have psychometrics available.
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Children's Sleep Questionnaire | Blocks 2 End of Treatment Week 14 | 2.94 units on a scale | Standard Deviation 1.458 |
| Atomoxetine Then Methylphenidate | Children's Sleep Questionnaire | Block 1 Baseline Week 0 | 5.14 units on a scale | Standard Deviation 0.756 |
| Atomoxetine Then Methylphenidate | Children's Sleep Questionnaire | Block 1 End of Treatment Week 6 | 3.20 units on a scale | Standard Deviation 1.641 |
| Atomoxetine Then Methylphenidate | Children's Sleep Questionnaire | Block 2 Baseline Week 8 | 4.75 units on a scale | Standard Deviation 0.938 |
| Methylphenidate Then Atomoxetine | Children's Sleep Questionnaire | Block 2 Baseline Week 8 | 4.55 units on a scale | Standard Deviation 1.233 |
| Methylphenidate Then Atomoxetine | Children's Sleep Questionnaire | Blocks 2 End of Treatment Week 14 | 3.43 units on a scale | Standard Deviation 1.46 |
| Methylphenidate Then Atomoxetine | Children's Sleep Questionnaire | Block 1 End of Treatment Week 6 | 2.83 units on a scale | Standard Deviation 1.446 |
| Methylphenidate Then Atomoxetine | Children's Sleep Questionnaire | Block 1 Baseline Week 0 | 5.09 units on a scale | Standard Deviation 0.716 |
Secondary
Clinical Global Impressions (CGI)- Severity
The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Clinical Global Impressions (CGI)- Severity | Block 1 Baseline Week 0 | 5.14 units on a scale | Standard Deviation 0.756 |
| Atomoxetine Then Methylphenidate | Clinical Global Impressions (CGI)- Severity | Block 1 End of Treatment Week 6 | 3.20 units on a scale | Standard Deviation 1.641 |
| Atomoxetine Then Methylphenidate | Clinical Global Impressions (CGI)- Severity | Block 2 Baseline Week 8 | 4.75 units on a scale | Standard Deviation 0.938 |
| Atomoxetine Then Methylphenidate | Clinical Global Impressions (CGI)- Severity | Blocks 2 End of Treatment Week 14 | 2.94 units on a scale | Standard Deviation 1.458 |
| Methylphenidate Then Atomoxetine | Clinical Global Impressions (CGI)- Severity | Blocks 2 End of Treatment Week 14 | 3.43 units on a scale | Standard Deviation 1.46 |
| Methylphenidate Then Atomoxetine | Clinical Global Impressions (CGI)- Severity | Block 1 Baseline Week 0 | 5.09 units on a scale | Standard Deviation 0.716 |
| Methylphenidate Then Atomoxetine | Clinical Global Impressions (CGI)- Severity | Block 2 Baseline Week 8 | 4.55 units on a scale | Standard Deviation 1.233 |
| Methylphenidate Then Atomoxetine | Clinical Global Impressions (CGI)- Severity | Block 1 End of Treatment Week 6 | 2.83 units on a scale | Standard Deviation 1.446 |
Secondary
Conners Teacher Rating Scale- Short
Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse
Time frame: up to 14 weeks
Population: data not collected
Secondary
Conners-Wells Adolescent Self Report
Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse
Time frame: up to 14 weeks
Population: data not collected
Secondary
Continuous Performance Test (CPT)
CPT Commissions, impulsive responses, higher score is worse. This scale is based on t-scores and does not have psychometrics available.
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Continuous Performance Test (CPT) | Block 1 Baseline Week 0 | 51.3277 T-scores | Standard Deviation 9.73401 |
| Atomoxetine Then Methylphenidate | Continuous Performance Test (CPT) | Block 1 End of Treatment Week 6 | 51.7005 T-scores | Standard Deviation 9.5779 |
| Atomoxetine Then Methylphenidate | Continuous Performance Test (CPT) | Block 2 Baseline Week 8 | 59.8788 T-scores | Standard Deviation 8.82849 |
| Atomoxetine Then Methylphenidate | Continuous Performance Test (CPT) | Blocks 2 End of Treatment Week 14 | 50.0763 T-scores | Standard Deviation 11.16765 |
| Methylphenidate Then Atomoxetine | Continuous Performance Test (CPT) | Blocks 2 End of Treatment Week 14 | 49.1616 T-scores | Standard Deviation 10.02259 |
| Methylphenidate Then Atomoxetine | Continuous Performance Test (CPT) | Block 1 Baseline Week 0 | 52.8976 T-scores | Standard Deviation 9.36961 |
| Methylphenidate Then Atomoxetine | Continuous Performance Test (CPT) | Block 2 Baseline Week 8 | 51.2159 T-scores | Standard Deviation 9.00827 |
| Methylphenidate Then Atomoxetine | Continuous Performance Test (CPT) | Block 1 End of Treatment Week 6 | 51.1713 T-scores | Standard Deviation 9.96929 |
Secondary
HALP Rebound Effects Questionnaire
Questionnaire, qualitative assesses symptoms of rebound (moodiness, irritability, aggression, and ADHD symptoms) when the medication wears off at night.
Time frame: up to 14 weeks
Population: data not collected
Secondary
Hyperactivity, Attention, and Learning Problems (HALP) Medical and Developmental History Questionnaire
Questionnaire, qualitative designed to collect family history, prenatal environmental influences, and developmental history.
Time frame: Measured at screening
Population: data not collected
Secondary
Permanent Mathematics Product Test (PERMP)
Measure of fluency in performance of simple mathematics, sum, lower = worse
Time frame: up to 14 weeks
Population: data not collected
Secondary
SES (Hollingshead)
Measure of socioeconomic status, score calculated from averaging likert responses, lower = worse
Time frame: up to 14 weeks
Population: data not collected
Secondary
Sleep Logs
Questionnaire, qualitative
Time frame: Measured daily throughout the study
Population: data not collected
Secondary
Social Skills Rating Scale (SSRS)- Parent Version
Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available.
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Social Skills Rating Scale (SSRS)- Parent Version | Block 1 Baseline Week 0 | 82.71 t-score | Standard Deviation 28.414 |
| Atomoxetine Then Methylphenidate | Social Skills Rating Scale (SSRS)- Parent Version | Block 1 End of Treatment Week 6 | 91.07 t-score | Standard Deviation 35.35 |
| Atomoxetine Then Methylphenidate | Social Skills Rating Scale (SSRS)- Parent Version | Block 2 Baseline Week 8 | 78.58 t-score | Standard Deviation 21.112 |
| Atomoxetine Then Methylphenidate | Social Skills Rating Scale (SSRS)- Parent Version | Blocks 2 End of Treatment Week 14 | 91.07 t-score | Standard Deviation 33.887 |
| Methylphenidate Then Atomoxetine | Social Skills Rating Scale (SSRS)- Parent Version | Blocks 2 End of Treatment Week 14 | 87.96 t-score | Standard Deviation 19.501 |
| Methylphenidate Then Atomoxetine | Social Skills Rating Scale (SSRS)- Parent Version | Block 1 Baseline Week 0 | 77.96 t-score | Standard Deviation 22.779 |
| Methylphenidate Then Atomoxetine | Social Skills Rating Scale (SSRS)- Parent Version | Block 2 Baseline Week 8 | 82.35 t-score | Standard Deviation 28.698 |
| Methylphenidate Then Atomoxetine | Social Skills Rating Scale (SSRS)- Parent Version | Block 1 End of Treatment Week 6 | 88.57 t-score | Standard Deviation 26.099 |
Secondary
Social Skills Rating Scale (SSRS)- Teacher Version
Measure of social skills, higher score is better. This scale is based on t-scores and does not have psychometrics available.
Time frame: up to 14 weeks
Population: data not collected
Secondary
Tics: Total Impairment
Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Tics: Total Impairment | Block 1 Baseline Week 0 | 5.304 units on a scale | Standard Deviation 22.4936 |
| Atomoxetine Then Methylphenidate | Tics: Total Impairment | Block 1 End of Treatment Week 6 | 1.737 units on a scale | Standard Deviation 13.1129 |
| Atomoxetine Then Methylphenidate | Tics: Total Impairment | Block 2 Baseline Week 8 | .000 units on a scale | Standard Deviation 0 |
| Atomoxetine Then Methylphenidate | Tics: Total Impairment | Blocks 2 End of Treatment Week 14 | .500 units on a scale | Standard Deviation 2.9014 |
| Methylphenidate Then Atomoxetine | Tics: Total Impairment | Block 1 End of Treatment Week 6 | .132 units on a scale | Standard Deviation 1.1471 |
| Methylphenidate Then Atomoxetine | Tics: Total Impairment | Blocks 2 End of Treatment Week 14 | .397 units on a scale | Standard Deviation 2.2543 |
| Methylphenidate Then Atomoxetine | Tics: Total Impairment | Block 1 Baseline Week 0 | .292 units on a scale | Standard Deviation 1.8571 |
| Methylphenidate Then Atomoxetine | Tics: Total Impairment | Block 2 Baseline Week 8 | .643 units on a scale | Standard Deviation 3.1762 |
Secondary
Tics: Total Motor
Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Tics: Total Motor | Block 1 Baseline Week 0 | .196 units on a scale | Standard Deviation 0.7727 |
| Atomoxetine Then Methylphenidate | Tics: Total Motor | Block 1 End of Treatment Week 6 | .053 units on a scale | Standard Deviation 0.2941 |
| Atomoxetine Then Methylphenidate | Tics: Total Motor | Block 2 Baseline Week 8 | .000 units on a scale | Standard Deviation 0 |
| Atomoxetine Then Methylphenidate | Tics: Total Motor | Blocks 2 End of Treatment Week 14 | .160 units on a scale | Standard Deviation 0.7656 |
| Methylphenidate Then Atomoxetine | Tics: Total Motor | Blocks 2 End of Treatment Week 14 | .143 units on a scale | Standard Deviation 0.6686 |
| Methylphenidate Then Atomoxetine | Tics: Total Motor | Block 1 Baseline Week 0 | .111 units on a scale | Standard Deviation 0.4297 |
| Methylphenidate Then Atomoxetine | Tics: Total Motor | Block 2 Baseline Week 8 | .214 units on a scale | Standard Deviation 0.8494 |
| Methylphenidate Then Atomoxetine | Tics: Total Motor | Block 1 End of Treatment Week 6 | 1.342 units on a scale | Standard Deviation 11.3544 |
Secondary
Tics: Total Phonic
Modified Yale Global Tic Severity Scale, sum, higher is worse. This score does not have psychometrics available. The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are: Total Motor Tic Score (0-25), Total Phonic Tic Score (0-25), Total Tic Score (0-50) Overall Impairment Rating (0-50).
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Tics: Total Phonic | Block 2 Baseline Week 8 | .039 units on a scale | Standard Deviation 0.196 |
| Atomoxetine Then Methylphenidate | Tics: Total Phonic | Block 1 Baseline Week 0 | .161 units on a scale | Standard Deviation 0.5649 |
| Atomoxetine Then Methylphenidate | Tics: Total Phonic | Blocks 2 End of Treatment Week 14 | .060 units on a scale | Standard Deviation 0.3136 |
| Atomoxetine Then Methylphenidate | Tics: Total Phonic | Block 1 End of Treatment Week 6 | .018 units on a scale | Standard Deviation 0.1325 |
| Methylphenidate Then Atomoxetine | Tics: Total Phonic | Blocks 2 End of Treatment Week 14 | .016 units on a scale | Standard Deviation 0.126 |
| Methylphenidate Then Atomoxetine | Tics: Total Phonic | Block 2 Baseline Week 8 | .057 units on a scale | Standard Deviation 0.2892 |
| Methylphenidate Then Atomoxetine | Tics: Total Phonic | Block 1 End of Treatment Week 6 | 1.329 units on a scale | Standard Deviation 11.3542 |
| Methylphenidate Then Atomoxetine | Tics: Total Phonic | Block 1 Baseline Week 0 | .028 units on a scale | Standard Deviation 0.1655 |
Secondary
Treatment Preference Survey
Time frame: Measured at ends of treatments one and two
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Atomoxetine Then Methylphenidate | Treatment Preference Survey | Treatment Preference of MPH | 50.5 percentage of participants |
| Atomoxetine Then Methylphenidate | Treatment Preference Survey | Treatment Preference of ATX | 41.8 percentage of participants |
| Methylphenidate Then Atomoxetine | Treatment Preference Survey | Treatment Preference of ATX | 27.4 percentage of participants |
| Methylphenidate Then Atomoxetine | Treatment Preference Survey | Treatment Preference of MPH | 51.9 percentage of participants |
Secondary
Vital Signs - Diastolic Blood Pressure
Diastole blood pressure - blood pressure when the heart muscle is between beats. normal range varies by age, sex, height and weight and can range from 34mm Hg to 90mmHg
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Vital Signs - Diastolic Blood Pressure | Block 1 End of Treatment Week 6 | 64.58 mm HG | Standard Deviation 8.638 |
| Atomoxetine Then Methylphenidate | Vital Signs - Diastolic Blood Pressure | Block 2 Baseline Week 8 | 62.33 mm HG | Standard Deviation 7.835 |
| Atomoxetine Then Methylphenidate | Vital Signs - Diastolic Blood Pressure | Blocks 2 End of Treatment Week 14 | 62.82 mm HG | Standard Deviation 7.325 |
| Atomoxetine Then Methylphenidate | Vital Signs - Diastolic Blood Pressure | Block 1 Baseline Week 0 | 61.78 mm HG | Standard Deviation 8.773 |
| Methylphenidate Then Atomoxetine | Vital Signs - Diastolic Blood Pressure | Block 1 Baseline Week 0 | 61.26 mm HG | Standard Deviation 7.882 |
| Methylphenidate Then Atomoxetine | Vital Signs - Diastolic Blood Pressure | Block 1 End of Treatment Week 6 | 62.77 mm HG | Standard Deviation 8.609 |
| Methylphenidate Then Atomoxetine | Vital Signs - Diastolic Blood Pressure | Blocks 2 End of Treatment Week 14 | 65.44 mm HG | Standard Deviation 8.699 |
| Methylphenidate Then Atomoxetine | Vital Signs - Diastolic Blood Pressure | Block 2 Baseline Week 8 | 61.28 mm HG | Standard Deviation 8.442 |
Secondary
Vital Signs - Pulse
Heartbeats per minute. Range varies from 50-205 depending on age and level of activity.
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Vital Signs - Pulse | Block 1 Baseline Week 0 | 78.20 beats per minute | Standard Deviation 12.927 |
| Atomoxetine Then Methylphenidate | Vital Signs - Pulse | Block 1 End of Treatment Week 6 | 84.46 beats per minute | Standard Deviation 14.697 |
| Atomoxetine Then Methylphenidate | Vital Signs - Pulse | Block 2 Baseline Week 8 | 82.96 beats per minute | Standard Deviation 13.931 |
| Atomoxetine Then Methylphenidate | Vital Signs - Pulse | Blocks 2 End of Treatment Week 14 | 84.85 beats per minute | Standard Deviation 13.314 |
| Methylphenidate Then Atomoxetine | Vital Signs - Pulse | Block 1 End of Treatment Week 6 | 82.05 beats per minute | Standard Deviation 12.915 |
| Methylphenidate Then Atomoxetine | Vital Signs - Pulse | Block 1 Baseline Week 0 | 77.49 beats per minute | Standard Deviation 12.365 |
| Methylphenidate Then Atomoxetine | Vital Signs - Pulse | Blocks 2 End of Treatment Week 14 | 84.31 beats per minute | Standard Deviation 13.095 |
| Methylphenidate Then Atomoxetine | Vital Signs - Pulse | Block 2 Baseline Week 8 | 81.30 beats per minute | Standard Deviation 12.683 |
Secondary
Vital Signs - Systolic Blood Pressure
Systolic blood pressure - the amount of pressure in arteries during contraction of the heart muscle Normal range varies by age, sex, height and weight and can range from 80mm Hg to 130mmHg
Time frame: up to 14 weeks
Population: see participant flow section for participants that did not complete blocks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine Then Methylphenidate | Vital Signs - Systolic Blood Pressure | Block 1 Baseline Week 0 | 101.11 mm HG | Standard Deviation 11.877 |
| Atomoxetine Then Methylphenidate | Vital Signs - Systolic Blood Pressure | Block 1 End of Treatment Week 6 | 102.10 mm HG | Standard Deviation 12.442 |
| Atomoxetine Then Methylphenidate | Vital Signs - Systolic Blood Pressure | Block 2 Baseline Week 8 | 99.74 mm HG | Standard Deviation 12.199 |
| Atomoxetine Then Methylphenidate | Vital Signs - Systolic Blood Pressure | Blocks 2 End of Treatment Week 14 | 102.34 mm HG | Standard Deviation 11.797 |
| Methylphenidate Then Atomoxetine | Vital Signs - Systolic Blood Pressure | Blocks 2 End of Treatment Week 14 | 102.51 mm HG | Standard Deviation 11.488 |
| Methylphenidate Then Atomoxetine | Vital Signs - Systolic Blood Pressure | Block 1 Baseline Week 0 | 101.60 mm HG | Standard Deviation 11.261 |
| Methylphenidate Then Atomoxetine | Vital Signs - Systolic Blood Pressure | Block 2 Baseline Week 8 | 101.29 mm HG | Standard Deviation 12.629 |
| Methylphenidate Then Atomoxetine | Vital Signs - Systolic Blood Pressure | Block 1 End of Treatment Week 6 | 103.29 mm HG | Standard Deviation 12.374 |