Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai; National Institute of Mental Health (NIMH)
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Atomoxetine Hydrochloride; Methylphenidate

Criteria

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