Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Lisdexamfetamine Dimesylate; Atomoxetine Hydrochloride
Intervention description: Oral 30, 50, or 70mg once-daily for 9 weeks; Oral 10mg to 100mg once-daily for 9 weeks
Intervention MeSH terms: Lisdexamfetamine Dimesylate; Atomoxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 267.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: ADHD

Summary:

      This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are
      judged by the Investigator to have had an inadequate response to methylphenidate therapy. The
      study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has had an historical or current inadequate response to methylphenidate (MPH)
             treatment. Inadequate response includes but is not limited to the presence of some
             residual symptoms, with associated impairment inadequate duration of action and/or
             variability of symptom control, and/or Investigator feels that the subject may derive
             benefit from an alternative drug treatment to MPH therapy.

          -  Subject is a male or female aged 6-17 years inclusive at the time of consent

          -  Subject must meet Diagnostic and Statistical Manual of Mental Disorders, fourth
             edition. - Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD based on
             a detailed psychiatric evaluation

          -  Subject must have a baseline ADHD-RS-IV total score 28.

        Exclusion Criteria:

          -  Subject has taken more than 1 MPH treatment (for example, 2 or more different MPH
             treatments). Examples include but are not limited to RITALIN immediate release (IR)
             and EQUASYM IR; MEDIKINET IR and CONCERTA; RITALIN long-acting LA and CONCERTA. Note:
             this does not include subjects who have taken IR MPH for dose titration on a
             short-term basis (for example, £4 weeks) with an adequate response

          -  In the Investigator's judgement, subject has failed to respond to more than 1 previous
             course(s) of MPH treatment. Failure to respond includes worsening of symptoms or no
             change/minimal improvement of symptoms.

          -  Subject has previously been exposed to STRATTERA or to amphetamine therapy

          -  Subject has previously demonstrated intolerable side effects to 1 MPH treatment which
             limited titration to acceptable efficacy or that required a decrease in dose resulting
             in unacceptable tolerability and/or efficacy

          -  Subject has a current, controlled (requiring a restricted medication) or uncontrolled,
             comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid
             Axis II disorder or severe Axis I disorder or other symptomatic manifestations, such
             as agitated states, marked anxiety, or tension that, in the opinion of the examining
             physician, will contraindicate treatment with SPD489 or STRATTERA or confound efficacy
             or safety assessments.

          -  Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary.