Effectiveness of Atomoxetine in Treating ADHD Symptoms in Children and Adolescents With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Intervention: Atomoxetine; Placebo
Intervention description: Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4.; Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: At the end of the 8-week double-blind, placebo-controlled study, participants randomized to placebo who are not responders at the end of 8 weeks will be treated with atomoxetine for 8 weeks during an open-label trial. All participants who are rated "much improved" or "very much improved" on the CGI-I following treatment with atomoxetine (i.e., atomoxetine responders) during either the 8-week placebo-controlled trial or the 8-week open-label phase for placebo nonresponders will be eligible to enter the 10-month open-label extension phase of the study.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 5 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Autistic Disorder; Autism Spectrum Disorder

Summary:

      This study will evaluate the effectiveness of atomoxetine in treating children with attention
      deficit hyperactivity disorder symptoms associated with autistic disorder, Asperger's
      syndrome, and pervasive developmental disorder, not otherwise specified.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of an autism spectrum disorder (autistic disorder, Asperger's syndrome, and
             pervasive developmental disorder, not otherwise specified).

          -  Significant hyperactivity, inattention, or impulsivity as determined by a score on an
             investigator-administered ADHD Rating Scale (ADHDRS)-Home Version that is at least 1.5
             standard deviations above the mean for age and sex

          -  Parent/caregiver's primary complaint about the child is inattention, hyperactivity,
             and/or impulsivity ("ADHD" symptoms)

          -  Symptoms present for 6 months prior to study entry

          -  Psychotropic drug-free for at least 2 weeks prior to starting study medication. This
             drug-free period will be 5 weeks for fluoxetine (Prozac).

        Exclusion Criteria:

          -  Weighs less than 15 kg (about 33 pounds)

          -  Any another psychiatric disorder that may require a different treatment, including
             psychotic disorders, major affective disorders, obsessive-compulsive disorder, panic
             disorder, or substance-related disorders

          -  Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
             diagnosis of Rett's disorder or childhood disintegrative disorder

          -  Presence of extreme aggression or self-injury

          -  Currently taking an effective psychotropic drug

          -  Currently using other medications that may be unsafe to take with atomoxetine (e.g.,
             potent CYP 2D6 inhibitors, intravenous albuterol, monoamine oxidase inhibitors[MAO])

          -  Inability to swallow study medication

          -  Presence of a medical condition that would make treatment with atomoxetine unsafe
             (e.g., unstable hypertension or cardiac disease, asthma requiring frequent treatment
             with albuterol, narrow angle glaucoma, pregnancy, etc.)

          -  Mental age of less than 18 months

          -  Previous adequate trial of atomoxetine

          -  Previous evidence of hypersensitivity or an allergic reaction to atomoxetine

          -  Clinically significant abnormalities in laboratory measures indicating an undiagnosed
             medical condition as determined by the study physician in discussion with the
             participant's primary care physician

          -  Clinically significant abnormalities on ECG as determined by a pediatric cardiologist

          -  Pregnant

          -  Initiation of a new psychosocial intervention within 90 days prior to starting study
             medication. Participants who have recently had a significant change in their
             psychosocial interventions will not be eligible until this intervention has been
             stable for 90 days in order to avoid confounding results of the study. Stable
             interventions (e.g., speech and occupational therapy) will be allowed to continue
             during the course of the study. Minor changes in ongoing treatment (e.g., missed
             therapy sessions due to holiday/vacation planned break in therapy due to school
             holidays) will not be considered significant.