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
Intervention: Dexmethylphenidate; Mixed Amphetamine Salts, ER; placebo
Intervention description: 10, 20, 25-30 mg.; 10, 20, 25-30; randomized placebo week during each 4 week period
Intervention MeSH terms: Amphetamine; Adderall; Dexmethylphenidate Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 9 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder; sleep; side effects; stimulants

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any ADHD subtype, determined by KSADS interview (Kaufman, Birmaher et al. 1997).
             Comorbidity will likewise be allowed, to ensure representation.

          -  Signed informed consent and assent

          -  Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating is greater than or
             equal to 4

          -  Findings on physical exam, laboratory studies, vital signs, and ECG are judged to be
             normal for age

          -  Pulse and blood pressure are within 95% of age and gender mean

          -  Able to complete study instruments and swallow capsules

          -  Willing to commit to the entire visit schedule for the study, including at least one
             visit to UIC Medical Center.

        Exclusion Criteria:

          -  Previous diagnosis of mental retardation

          -  Non-responder to either medication at the doses offered in the study in an adequate
             trial

          -  Must not have experienced disabling adverse effects with either medication

          -  Concomitant psychotropic medications are required or medications which might have a
             CNS effect

          -  Any other medical condition which represents a contraindication for either treatment
             is present

          -  History of alcohol or drug abuse in the past 3 months, or a positive urinary toxic
             screen on initial evaluation that is not explained by a time-limited medical
             circumstance

          -  Females of childbearing age who are sexually active, do not use acceptable birth
             control (double protection method), and after counseling, are unwilling to do so

          -  History of allergic reactions to multiple medications

          -  A history of psychosis

          -  Diagnosis of bipolar disorder