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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
232
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.
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.
University of Illinois, Chicago - Institute for Juvenile Research
Chicago, Illinois, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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
Treatment Preference Survey
Time frame: Measured at ends of treatments one and two
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
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
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
Social Skills Rating Scale (SSRS)- Parent Version
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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
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
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
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
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
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
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
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
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
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
Vital Signs - Pulse
Heartbeats per minute. Range varies from 50-205 depending on age and level of activity.
Time frame: up to 14 weeks
SES (Hollingshead)
Measure of socioeconomic status, score calculated from averaging likert responses, lower = worse
Time frame: up to 14 weeks
Conners-Wells Adolescent Self Report
Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse
Time frame: up to 14 weeks
Conners Teacher Rating Scale- Short
Standardized measure of ADHD symptoms and severity, norm referenced T scores, higher = worse
Time frame: up to 14 weeks
Child Behavior Checklist (CBCL)
CBCL Total Score, measure of psychosocial problems, higher is worse.
Time frame: Measured at screening
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
Permanent Mathematics Product Test (PERMP)
Measure of fluency in performance of simple mathematics, sum, lower = worse
Time frame: up to 14 weeks
Actigraphy
Measure of physical activity
Time frame: Measured daily throughout the study
Sleep Logs
Questionnaire, qualitative
Time frame: Measured daily throughout the study
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
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