Comparing the Effectiveness of New Versus Older Treatments for Attention Deficit Hyperactivity Disorder (The NOTA Study)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate transdermal system; Lisdexamfetamine dimesylate; Osmotic-release oral system methylphenidate (OROS MPH); Mixed amphetamine salts extended release
Intervention description: Not specified in protocol; determined by local standard of care.; Not specified in protocol; determined by local standard of care.; Not specified in protocol; determined by local standard of care.; Not specified in protocol; determined by local standard of care.
Intervention MeSH terms: Methylphenidate; Amphetamine; Lisdexamfetamine Dimesylate; Adderall
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 228.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: ADHD; Methylphenidate; Amphetamine

Summary:

      This study will determine whether two new psychostimulant medications are more effective,
      tolerable, and acceptable than two older medications for treating attention deficit
      hyperactivity disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV diagnostic criteria for ADHD combined, hyperactive/impulsive, or
             inattentive subtype

          -  Outpatient at study entry

          -  Speaks English

          -  Willing to be randomly assigned to one of the study treatment options as outlined in
             the protocol

          -  No known significant history of cardiovascular disorders, including pre-existing
             congenital heart disease, structural heart disease, known clinically significant
             electrocardiogram (ECG) abnormality, or other clinically significant cardiac disorder

          -  Willing to initiate study medication for ADHD within 7 days of the study baseline
             visit

          -  May be receiving stable treatment with other drug for a comorbid disorder, defined as
             no changes in dose or form of drug treatment for at least 2 weeks prior to the study
             enrollment visit

          -  May be receiving psychosocial interventions for ADHD or a comorbid disorder, defined
             as no changes in form of psychosocial treatment for at least 4 weeks prior to the
             study enrollment visit

        Exclusion Criteria:

          -  Hypersensitivity to study medication

          -  Inpatient status at study entry

          -  Currently taking another medication for ADHD, including another psychostimulant,
             atomoxetine, or bupropion

          -  Receiving treatment with a tricyclic antidepressant at study enrollment, with the
             exception of low-dose imipramine for enuresis or amitriptyline for chronic pain

          -  Received treatment with a monoamine oxidase inhibitor (MAOI) within the past 30 days

          -  Psychostimulant drug dependence, bipolar disorder, or schizophrenia

          -  Presence of psychosis

          -  Severe mental retardation

          -  Autism or Asperger's syndrome

          -  Active suicidal ideation

          -  Unable or unwilling to comply with the protocol

          -  Demonstrates a lack of benefit from, an intolerance to, or contraindication to
             psychostimulant medicine

          -  Presence of other clinically significant medical conditions, including
             hyperthyroidism, epilepsy or other seizure disorder, any condition for which an
             increase in blood pressure or heart rate would be problematic, glaucoma or other
             significant eye disease for which a psychostimulant would be problematic, or
             pre-existing gastrointestinal obstruction with gastrointestinal narrowing

          -  Pregnant or positive result of pregnancy test