Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of a single drug versus a combination of drugs in
      treating attention deficit hyperactivity disorder in children.
    

Detailed description: 
      Attention deficit hyperactivity disorder (ADHD) is one of the most common childhood mental
      disorders. Children with ADHD have impaired functioning in multiple settings, including home
      and school. They also have difficulty relating with peers. If left untreated, the disorder
      may cause adverse effects that can last into adolescence and adulthood. Stimulant
      medications, such as methylphenidate, are effective in reducing ADHD symptoms on a short-term
      basis. However, few long-term benefits in academic or general functioning from current ADHD
      therapies have been demonstrated. Focalin XR is a stimulant medication that is FDA-approved
      for treating ADHD. Guanfacine is another medication that is currently approved for the
      treatment of hypertension, but has long been used for treating ADHD. This study will
      determine the effectiveness of a combination of Focalin XR and guanfacine in enhancing
      cognitive functioning and improving the long-term benefit of ADHD treatment.

      Participants in this study will be randomly assigned to one of three treatment regimens:
      Methylphenidate (Focalin XR) and placebo; guanfacine and placebo; or Focalin XR and
      guanfacine. The study will be conducted in two phases: an 8-week double-blind treatment phase
      and a 12-month open-label treatment phase. In Phase I, one third of participants will receive
      placebo for the initial 4 weeks, followed by Focalin XR alone for the remaining 4 weeks. All
      other participants will receive their assigned medications for the full 8 weeks. All
      participants will attend two study visits prior to beginning treatment and one study visit
      per week throughout Phase I. At the end of Phase I, treatment assignments will be unblinded.
      Participants who experienced adequate improvement with their assigned treatment will then
      continue in Phase II on the same medication(s) for an additional 12 months. Participants will
      attend study visits once per month until the end of the study. Study visits will include
      self-report measures, clinical assessments, and cognitive testing. Participants will also
      undergo four electroencephalography (EEG) tests and two fMRI scans over the course of the
      study. All Phase II participants will receive a follow-up telephone call 1 month after the
      final study visit.
    

Intervention name(s): Guanfacine; Methylphenidate (MPH)
Intervention type(s): Drug; Drug
Intervention description(s): Week 1: 0.5 mg twice daily; Week 2: 1 mg twice daily; Week 3: 1.5 mg twice daily; Weeks 4 through 8: best dose as determined by efficacy measures; Participants less than 25 kg will receive 10 mg once daily for Week 5, 20 mg once daily for Week 6, and 30 mg once daily for Week 7. Subjects greater than 25 kg will receive 20 mg once daily for Week 5, 30 mg once daily for Week 6, 40 mg once daily for Week 7, and best doses as determined by efficacy measures for Week 8.
Other intervention name(s): Tenex; Focalin XR
Intervention MeSH terms: Guanfacine; Methylphenidate; Dexmethylphenidate Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Guanfacine; Methylphenidate; Focalin XR; Pediatric; Cognitive function; Combination therapy