Effectiveness of Atomoxetine in Treating ADHD Symptoms in Children and Adolescents With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Autism is a developmental disorder that can cause severe and pervasive impairment in
      thinking, feeling, language, and the ability to relate to others. It is usually first
      diagnosed in early childhood. Children with autism demonstrate repetitive behaviors or
      interests and deficits in social interaction, verbal communication, and nonverbal
      communication. In addition, they often have unusual responses to sensory experiences, such as
      certain sounds or the way objects look. Some symptoms of attention deficit hyperactivity
      disorder (ADHD), such as inattention, hyperactivity, and impulsivity, are also associated
      with autism. Atomoxetine is a selective norepinephrine reuptake inhibitor that is used to
      treat ADHD. It works differently, however, than stimulant drugs and may help to reduce ADHD
      symptoms in children with autism. This study will evaluate the effectiveness of atomoxetine
      in treating children with ADHD symptoms associated with autism.

      Potential participants will first attend a screening visit, which will include a psychiatric
      diagnostic interview, a practice session for swallowing pill capsules, a physical exam, an
      electrocardiogram (ECG), a blood test, and an assessment of pubertal stage. Females of
      childbearing age will also undergo a urine pregnancy test. In an initial double-blind study
      phase, eligible participants will be randomly assigned to receive either atomoxetine or
      placebo for 8 weeks. A baseline visit will include several rating scales, observations, and
      an interview to assess adaptive functioning. These measures and procedures will be used to
      keep track of symptoms, side effects, and behavior that could change during the study.
      Children who are assigned to placebo and do not notice an improvement in their ADHD symptoms
      will be given the opportunity to receive atomoxetine at the end of 8 weeks. Study visits will
      occur once a week for 4 weeks, and then every other week for the remainder of the 8 weeks.
      During these visits, many of the baseline questionnaires and interviews will be repeated. At
      the Week 8 visit, the physical exam, ECG, blood tests, and some baseline questionnaires will
      also be repeated. All children who respond well to atomoxetine may continue taking the drug
      for an additional 10 months. During this time, participants will report to the clinic once a
      month for the first 4 months, then once at the end of 7 months, and finally once at the end
      of 10 months. The same measures and procedures that were done during the 8-week phase will be
      done during the 10-month phase of this study.
    

Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
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)
Primary purpose: Treatment
Keywords: Autistic Disorder; Autism Spectrum Disorder