Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity … (NCT00429273) | Clinical Trial Compass
CompletedPhase 4
Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
United States212 participantsStarted 2007-01
Plain-language summary
This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
Who can participate
Age range
7 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of DSM-IV ADHD by K-SADS-PL and confirmed by clinical interview
* Clinical Global Impression-Severity score of at least 4 for ADHD
* Resided with primary caretaker for at least 6 months prior to study entry
Exclusion Criteria:
* History of autism, pervasive developmental disorder, chronic tic disorder, psychosis, or bipolar disorder
* Current major depression or panic disorder
* Systolic or diastolic blood pressure at screening greater than the 95th percentile or less than the 5th percentile for age and body mass index (BMI)
* Any medical condition that might make stimulant or alpha agonist therapy medically inadvisable
* Need for chronic use of other medications with central nervous system effects
* Pregnant, breastfeeding, or beyond menarche and has a positive urine pregnancy test
* History of structural heart defects, syncope, or fainting while exercising
* Clinically significant cardiac abnormality as determined by echocardiogram (ECG) at study entry
* Mental retardation as determined by clinical functional assessment and an IQ estimate of less than 70 based on Wechsler Adult Intelligence Scale (WAIS) subtests
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
ADHD IV Rating Scale (Attention Deficit Hyperactivity Disorder Rating Scale)