The Effects of ADHD Medication (TEAM) Study
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effects of receiving and then discontinuing methylphenidate (MPH) in
      children with ADHD. After receiving MPH for 8 weeks, participants will be randomized to
      either discontinue MPH (and receive placebo) OR remain on MPH for 4 weeks.
    

Detailed description: 
      The stimulant methylphenidate (MPH) is the most commonly prescribed psychoactive medication
      in children. An abundance of studies attest to the efficacy of MPH for attenuating
      inattentive, hyperactive, and impulsive symptoms in children with ADHD. Despite its efficacy,
      most children with ADHD who are prescribed MPH have poor continuity of treatment for a
      variety of reasons, including forgetting to administer the medication and delays obtaining
      refills. In addition, it is an accepted clinical practice for physicians to omit MPH for
      periods of time, such as during the summer or on weekends (i.e., drug holidays). Since MPH
      discontinuation is considered to be benign, many clinicians do not employ any special
      procedures or inform families of any special precautions in regard to its cessation. However,
      increasing evidence suggests that the pharmacological effects of MPH cause lasting changes in
      brain neurochemistry that persist beyond medication discontinuation. Moreover, these
      neurobiological effects of discontinuation appear to have neurobehavioral consequences. There
      is a critical need to better understand the breadth and magnitude of the neurobehavioral
      effects caused by MPH discontinuation as well as to better understand the temporal trajectory
      of these deleterious effects. Hence, the primary goal of the proposed research is to conduct
      the first randomized, double-blind, placebo-controlled trial specifically designed to study
      the negative effects of MPH discontinuation at multiple time points. 180 children diagnosed
      with ADHD will participate across two recruitment sites. After undergoing a 4-week MPH
      titration trial and 4-week MPH maintenance phase, participants will be randomized to either
      discontinue MPH (and receive placebo) OR remain on MPH for 4 weeks. Comprehensive multi-time
      point, multi-informant (parents, teachers, study staff) and multi-modal (behavior/mood/affect
      ratings scales, direct behavior observations, standardized testing) assessments will be used
      to assess a broad range of neurobehavioral outcomes. We will examine the magnitude and time
      course of effects of MPH discontinuation on behavioral as well as cognitive and academic
      functioning in children with ADHD. Furthermore, we will examine moderators of the adverse
      effects of MPH discontinuation on these outcomes to aid in the identification of those who
      are at increased risk.
    

Intervention name(s): OROS-Methylphenidate (MPH)
Intervention type(s): Drug
Intervention description(s): OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; inattention; hyperactivity; methylphenidate