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
Study type: Interventional
Phase: Phase 4

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. 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.
    

Intervention name(s): Atomoxetine; Methylphenidate
Intervention type(s): Drug; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Child; Adolescent; School