Effectiveness of Atomoxetine in Treating ADHD Symptoms in Children and Adolescents With Autism

Sponsored by National Institute of Mental Health (NIMH)

Phase Quota
Phase 3

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.

Study Start Date: July 2007

Estimated Completion Date: October 2015

Specialties: Pediatrics: Child/Adolescent Psych Psychiatry: Child/Adolescent Psych,Mood Disorders,Neuro/Psych Pharmacol,Neuropsych Sciences Neurology: Peds Neurology Family Medicine: Peds Family Medicine,Psychiatry Pharmacy: Neuro/Psych pharmacology Nurse Practitioner: Mental Health


  • Drug: Placebo
  • Drug: Atomoxetine

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
  • 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 [MAO] inhibitors)
  • 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

Study Locations And Contact Information

  • Lurie Center MassGeneral Hospital, Lexington Massachusetts
    Contact: Jennifer Mullett RN CCRP 781-860-1711
  • Christian Sarkine Autism Treatment Center at Riley Hospital for Children, Indianapolis Indiana

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