An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).
Condition: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders
Intervention: atomoxetine 0.5 mg/kg/day; placebo; atomoxetine 1.2 mg/kg/day; atomoxetine 1.2-1.4 mg/kg/day
Intervention description: atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO); atomoxetine 1.2 mg/kg/day QD, PO; atomoxetine 1.2 - 1.4 mg/kg/day QD, PO
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: 139.0
Sex: All
Minimum age: 6 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric
      patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD).
      The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and
      ODD symptoms in patients non responders to a previous psychological intervention with parent
      support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid
      conditions associated with ADHD and ODD will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Child or adolescent patients, male or female outpatients, who are at least 6 years of
             age, but must not yet have reached their 16th birthday prior to Visit 1, when informed
             consent is obtained.

          -  Patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth
             Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and ODD and score at least
             1.5 standard deviations above the age norm for their diagnostic subtype using
             published norms for the Swanson, Nolan and Pelham Questionnaire:
             Attention-Deficit/Hyperactivity Disorder (SNAP-IV ADHD) Subscale score at both Visit 1
             and 2.

          -  They must also have a SNAP-IV ODD subscale score of at least 15 at both Visit 1 and
             Visit 2.

          -  Other comorbid conditions, are allowed but the diagnosis of ADHD and ODD must be the
             patient's primary diagnosis.

          -  Patients must be of normal intelligence in the judgment of the investigator (that is,
             without a general impairment of intelligence and likely, in the investigator's
             judgement, to achieve a score of greater than or equal to 70 on an Intelligence
             Quotient (IQ) test). The administration of a formal IQ test is not an entry
             requirement for the study. Specific learning disabilities are not considered general
             impairment of intelligence.

        Exclusion Criteria:

          -  Patients who weigh less than 20 kilograms (kg) at study entry (Visit 1).

          -  Patients who have a documented history of Bipolar I or II disorder, any history of
             psychosis or pervasive development disorder.

          -  Patients with a history of any seizure disorder (other than febrile seizures) or
             patients who have taken (or are currently taking) anticonvulsants for seizure control
             are not eligible to participate.

          -  Patients at serious suicidal risk as assessed by the investigator.

          -  Patients who, in the investigator's judgment, are likely to need psychotropic
             medications apart from the drug under the study, including health-food supplements
             that the investigator feels have central nervous system activity (for example, St.
             John's Wort, melatonin).