Stimulant Versus Nonstimulant Medication for Attention Deficit Hyperactivity Disorder in Children
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine; Methylphenidate
Intervention description: 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.
Intervention MeSH terms: Methylphenidate; Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 232.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: ADHD; Child; Adolescent; School

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.
    

Eligibility 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