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
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Attention deficit hyperactivity disorder (ADHD) is characterized by impulsiveness,
      hyperactivity, and inattention. It is seen primarily in children and adolescents and is often
      treated with psychostimulant medications. Osmotic-release oral system (OROS) methylphenidate,
      brand name Concerta, and mixed amphetamine salts extended release, brand name Adderall XR,
      are psychostimulant medications that have shown both efficacy (that they can have therapeutic
      benefits) and effectiveness (that they typically have therapeutic benefits in practice). Two
      newer psychostimulant medications-lisdexamfetamine dimesylate, brand name Vyvanse, and
      methylphenidate transdermal system, brand name Daytrana-have shown efficacy but have not been
      tested for effectiveness, nor have they been tested head-to-head against the older
      psychostimulants. This study will test the effectiveness, tolerability (lack of side
      effects), and acceptability (ease of use for patients) of the two newer psychostimulant
      medications and compare them to each other and to the two older psychostimulants.

      Participation in this study will last 6 weeks, although some treatments may continue past the
      end of the study. At enrollment, participants will undergo a series of baseline evaluations.
      These will include interviews and assessments of ADHD symptoms, concurrent psychiatric
      disorders, medical and psychiatric history, family history of mental illness, risk and
      protective factors, other treatments, treatment expectancy of both the youth and parent, and
      vital signs. In consultation with their doctors, participants will be allowed to exclude
      zero, one, or two of the study medications; if they choose to exclude both of the new ADHD
      medications, they will not able to participate in the study. Participants will then be
      randomly assigned to one of the treatments they choose to include. They will receive a
      prescription for the medication and instructions for how to use it from their doctors; the
      study protocol does not specify a particular treatment regimen. Participants will undergo a
      second set of evaluations after 6 weeks of treatment or before, if the treatment ends
      earlier. This will include interviews and assessments similar to those administered at
      baseline as well as evaluation of any medication side effects.
    

Intervention name(s): Methylphenidate transdermal system; Lisdexamfetamine dimesylate; Osmotic-release oral system methylphenidate (OROS MPH); Mixed amphetamine salts extended release
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Daytrana; Vyvanse; Concerta; Adderall XR
Intervention MeSH terms: Methylphenidate; Amphetamine; Lisdexamfetamine Dimesylate; Adderall
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Methylphenidate; Amphetamine