Status:
COMPLETED
Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
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. Howe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00183391
Start Date
July 1 2005
End Date
June 1 2011
Last Update
June 6 2018
Active Locations (2)
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1
University of Illinois, Chicago - Institute for Juvenile Research
Chicago, Illinois, United States, 60612
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029