Efficacy and Safety of Atomoxetine in Children With Recent Diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine Hydrochloride; placebo
Intervention MeSH terms: 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: 151.0
Sex: All
Minimum age: 6 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      Double blinded clinical trial placebo controlled in 153 children (planned enrollment) with
      recent diagnosis of ADHD. Patients will be randomized to atomoxetine or placebo arm (2:1).
      The double blinded period will last 12 weeks and the treatment open phase will last up to 1
      year, and atomoxetine treatment will be administered.

      A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Child or adolescent patients must be at least 6 years of age, but must not yet have
             reached their 16th birthday prior to Visit 1, when informed consent is obtained.

          2. Patients must meet the Diagnostic and Statistical Manual for Mental Disorders, Fourth
             Edition Text Revision (DSM-IV-TR) diagnostic criteria for ADHD. For the purposes of
             this study the diagnosis of ADHD will be confirmed during Visit 1 by administering the
             K-SADS-PL. Patients must also have an ADHDRS-IV-Parent:Inv score at least 1.5 standard
             deviations above the age norm for their diagnostic subtype at both Visit 1 and Visit
             2. In addition, they must have a CGI-ADHD-S score 4 at both Visit 1 and Visit 2.

          3. Patients must have a newly diagnosed case of ADHD. Newly diagnosed case of ADHD means
             that a specialist (including pediatrician, child psychiatrist, or child neurologist)
             or child psychologist has diagnosed ADHD (according DSM-IV-TR or International
             Statistical Classification of Diseases and Related Health Problems [World Health
             Organisation; 10th Revision] [ICD 10] criteria) within 3 months prior to Visit 1.

        Exclusion Criteria:

          1. Patients with history of ADHD diagnosis longer than 3 months prior to Visit 1.
             Diagnosis of ADHD means that a specialist (including pediatrician, child psychiatrist,
             or child neurologist) or child psychologist has diagnosed ADHD (according DSM-IV-TR or
             ICD 10 criteria) and has registered it in medical records or verbally informed parents
             about this diagnosis.

          2. Patients who weigh less than 20 kg at study entry (Visit 1). If a patient's weight
             changes after Visit 1 to a value outside of the stated range, the patient will still
             be eligible, and the weight should be rounded to the nearest value within the above
             range for dosing purposes.