Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate how children and adolescents with Attention Deficit/
      Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant
      medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is
      to evaluate if there are differences in sleep and other side effects, such as changes in mood
      or loss of appetite, which can occur with stimulant medications. A third purpose is to
      determine if there are differences in the characteristics of individuals who respond better
      to either of the medications.

      This research is being done because the investigators do not know if one of these two
      commonly used treatments is better tolerated than the other. Children and adolescents with
      ADHD often have a hard time sitting still, playing quietly, finishing things they start,
      paying attention, waiting their turn, and not distracting others. These medications improve
      these symptoms, but sometimes affect sleep, appetite, or mood.

      It is hypothesized that at effective and frequently prescribed doses, Adderall will be
      associated with insomnia, more stimulant side effects, and decreased tolerability during an
      acute trial relative to Focalin.
    

Detailed description: 
      ADHD is often treated with stimulant medications, which have demonstrated short-term efficacy
      in numerous trials. However, treatment is often discontinued prematurely. Although ADHD often
      persists through adolescence, approximately half of all children who are treated with a
      stimulant medication discontinue treatment within one year (Charach, Ickowicz et al. 2004).
      Presumably, tolerability and treatment compliance are highly related to the side effect
      profile of stimulant medications (Schachar, Jadad et al. 2002). Sleep problems, particularly
      insomnia, are frequently associated with ADHD and are often exacerbated by stimulant
      medications, particularly at higher doses. Other frequent stimulant side effects are
      decreased appetite and mood lability (dysphoria/euphoria). Little is known about the relative
      effects of different stimulant formulations and dosages (i.e amphetamine, methylphenidate,
      dexmethylphenidate) on sleep and tolerability. There is some preliminary data with short
      acting stimulants suggesting a higher prevalence of sleep and appetite problems with
      amphetamine relative to mph (Pelham, Aronoff et al. 1999). Several studies indicate that
      sleep and other stimulant side effects are dose related (Stein, Sarampote et al. 2003),
      although this has not been found in all studies. Moreover, it is unclear if there are
      differences between long-acting amphetamine and methylphenidate based stimulants in their
      side effect profile and tolerability. Thus, we will directly compare these two long acting
      stimulant medications on their side effect profile and tolerability, including measures of
      sleep, mood, and evening behavior (e.g., family conflicts). The recently developed extended
      release formulation of dexmethylphenidate will be compared to one of the most common
      treatments for ADHD, extended release formulation of mixed amphetamine salts. The subject
      population will be older children and adolescents (10-17) with ADHD who are most likely to be
      treated with moderate to higher dose levels of stimulant medications and can complete all
      self-report measures.
    

Intervention name(s): Dexmethylphenidate; Mixed Amphetamine Salts, ER; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10, 20, 25-30 mg.; 10, 20, 25-30; randomized placebo week during each 4 week period
Other intervention name(s): Focalin XR; Adderall XR
Intervention MeSH terms: Amphetamine; Adderall; Dexmethylphenidate Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; sleep; side effects; stimulants