Atomoxetine Pilot Study in Preschool Children With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if atomoxetine (a common brand name is Strattera),
      a medicine that is used for treating older children with Attention Deficit and Hyperactivity
      Disorder (ADHD), is also safe and helpful for ADHD problems in young children. While
      atomoxetine is not approved by the FDA for use in children younger than 6 years, the FDA has
      given permission to study this drug in this age group.
    

Detailed description: 
      Prevalence of Attention Deficit Hyperactivity Disorder ADHD in school age children is
      estimated to be 2% to 11%. Many preschool age children have problems with hyperactivity,
      short attention span, impulsivity and other behavior dyscontrol and are quite likely to
      continue to have difficulties in elementary school years. Many of these children are referred
      for diagnosis and management of their difficult behavior and are diagnosed with ADHD.
      Children with ADHD often display disruptive behaviors that interfere with their functioning
      at school, home and in the community due to symptoms of hyperactivity, impulsiveness and
      inattention.

      Symptoms of ADHD may be underdiagnosed and undertreated in preschool children. Preschool
      children with ADHD often require vigilant monitoring and supervision to ensure their safety.
      Symptoms of impulsivity, hyperactivity and distractibility often limit the effectiveness of
      educational and behavioral interventions. Hence, it is important to treat the symptoms of
      ADHD in children at an early age. Early intervention in children with ADHD may have an impact
      in the course of illness by abating longer-term disability in vulnerable children.

      Pharmacological agents are considered a standard treatment recommendation in children with
      ADHD. Recently, a non-stimulant pharmacological agent, atomoxetine (ATMX), has been reported
      to be effective and safe in school-age children with ADHD. Data are not available for the
      usefulness of ATMX in children younger than 6 years. However, parents of younger children
      with ADHD are frequently asking practicing physicians to prescribe ATMX for their child since
      they do not want their child taking stimulants.

      There is a need to carry out treatment trials with ATMX in preschool children with ADHD in
      order to collect data on how effective the drug is, its safety, and the best doses to
      administer to children with ADHD. Therefore, this study will be a pilot project to obtain
      preliminary data that will then be used to help set up a larger study that will examine
      preschool children with ADHD.

      All subjects will be screened for eligibility inclusion and exclusion criteria. Since other
      therapies including behavior therapy are routinely indicated, for ethical reasons subjects
      will continue to receive all concurrent therapies throughout the study period. All concurrent
      therapies will be stabilized for a minimum period of 2 weeks prior to the child's entry into
      the drug phase of the study. At each medication follow-up visit, a detailed history will be
      obtained and recorded for all concurrent treatments.

      If a child enrolls in this study, his/her participation will last approximately 7 to 13 weeks
      with a minimum of 7 outpatient daytime visits. The visits will be weekly in the beginning and
      then every other week once the child is taking an optimum dose of atomoxetine. Visits will
      take 1-5 hours each and will take place at the Department of Psychiatry in the Arizona Health
      Sciences Center (Tucson). The study consists of 2 periods.

      Screening assessment: The screening visit(s) is/are used to determine if a child is eligible
      for participation. The child's teacher/daycare provider (with the parent's permission) and
      the parent(s) will need to complete some forms describing the child's problems with
      overactivity, impulsivity and inattention. The screening assessments may be completed over
      1-2 visits. Each visit will take about 3-5 hours to complete. The research staff will
      evaluate each child to see if s/he has ADHD. Parents will be interviewed about their child's
      behavior. The child's teacher will be given several rating forms to complete. Parents will be
      asked to complete some questions about their child's development. Both parents (if available)
      and will be interviewed about their family histories.

      After it is determined that a child is eligible to participate, there will be a baseline
      visit. The child's previous ineffective medication will be discontinued. The ratings done at
      the first visit will be repeated, including both the teacher and parent rating scales. The
      child will have vital signs taken including height, weight, blood pressure and pulse rate, an
      electrocardiogram (EKG) (a test of heart rhythm recorded by putting sticky pads on the
      chest), a urine test and a blood test (about 10cc or 1 tablespoon). The doctor will ask the
      parents about the child's medical history. Parents will be told about any abnormal laboratory
      values or physical findings that may be discovered during this study. This information will
      also be available to the child's pediatrician if the parents request this be done.

      Medication phase: After screening assessments are completed, the child will enter the
      medication phase of the study. The child will be started on atomoxetine at 0.5 mg/kg/day,
      with the dosage increased to a maximum dose of 1.8 mg/kg/day. The dose will be determined by
      how well the child responds to and tolerates the drug. The dose will be given twice a day to
      minimize side effects. After the optimum dose is determined, the child will be kept at this
      stable dose for 4 weeks.

      At each visit, vital signs will be taken including height, weight, blood pressure, and pulse
      rate. Interviews, play assessments, checklist, and questionnaires will be completed at each
      visit in order to assess how well the child is doing, and whether there are symptoms or side
      effects. Teachers will also continue to be asked to fill out assessments.

      If the child's behavior gets worse or s/he experiences any side effects, parents should call
      the study doctor immediately and it will be determined if any changes in the child's
      treatment will need to be made. Participants will be given a card with telephone numbers and
      important information needed to get in touch with the doctor at any time, day or night.

      Some of the screening assessments will be videotaped/audiotaped. These tapes will be used for
      later coding, supervision of the child's doctor/therapist, review by offsite
      consultants/mentors, training of other doctors/therapists, and/or for presentations at
      conferences. The tapes can be erased at any time during or after the session at the parent's
      request.
    

Intervention name(s): ATMX
Intervention type(s): Drug
Intervention description(s): Medication phase: After screening assessments are completed, the child will enter the medication phase of the study. The child will be started on atomoxetine at 0.5 mg/kg/day, with the dosage increased to a maximum dose of 1.8 mg/kg/day. The dose will be determined by how well the child responds to and tolerates the drug. The dose will be given twice a day to minimize side effects. After the optimum dose is determined, the child will be kept at this stable dose for 4 weeks.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; atomoxetine; preschool children; efficacy; safety