Effectiveness of an Extended Release Stimulant Medication in Treating Preschool Children With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study will evaluate the safety and effectiveness of extended release mixed amphetamine
      salts in treating preschool children with attention deficit hyperactivity disorder.
    

Detailed description: 
      Attention deficit hyperactivity disorder (ADHD) is a common developmental disorder that
      affects between 4% and 12% of school-aged children. Children with ADHD often show symptoms of
      hyperactivity, inattention, inability to sit still, trouble listening, excessive talking, and
      aggression. ADHD is generally not diagnosed and treated in children less than 6 years old
      because some symptoms of ADHD are difficult to distinguish from normal behaviors of
      preschool-aged children. However, some preschool children who exhibit symptoms indicative of
      ADHD and who have been carefully diagnosed by a health professional may benefit from early
      treatment to lower risk for functional impairment later in childhood. Currently,
      environmental changes, parent effectiveness training, and behavior therapy are the commonly
      used treatments for preschoolers with ADHD symptoms, but not all preschoolers respond well to
      such behavioral interventions. These children may benefit from medication treatment; however,
      the safety and effectiveness of ADHD medications in treating preschool-aged children is not
      well known. Extended release mixed amphetamine salts (XR-MAS), a stimulant medication, is a
      commonly prescribed and approved medication for treating ADHD in children 6 years and older.
      Further study is needed to determine how XR-MAS affects preschool-aged children with ADHD
      symptoms. This study will compare the safety and effectiveness of XR-MAS versus placebo in
      treating preschool children with ADHD.

      Participation in this study will last 6 weeks. All participants will first undergo rigorous
      psychiatric assessments to confirm their diagnosis of ADHD. Eligible participants will then
      be assigned randomly to receive treatment with either XR-MAS then placebo or placebo then
      XR-MAS. Participants will take their assigned XR-MAS or placebo medications for 3 weeks and
      then cross over to the other medication for an additional 3 weeks of treatment. Rating scale
      scores will be collected weekly from parents and teachers to assess symptom response and
      measures of safety.
    

Intervention name(s): Sequence 1: XR-MAS then placebo; Sequence 2 Placebo then XR-MAS
Intervention type(s): Drug; Drug
Intervention description(s): XR-MAS given in non-identifying 5 mg capsules with instructions to start 1 capsule (5 mg/d) for one week, then increase to 2 capsules (10 mg/d) for week two, and 3 caps (15 mg/d) for week 3 following flexible, forced titration based on response and tolerance.; PBO given in non-identifying 5 mg capsules with instructions to start 1 capsule (5 mg/d) for one week, then increase to 2 capsules (10 mg/d) for week two, and 3 caps (15 mg/d) for week 3 following flexible, forced titration based on response and tolerance.
Other intervention name(s): Adderall XR; IND# 58,037
Intervention MeSH terms: Adderall
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Preschool; Children; ADHD; Medication; Controlled Study; Placebo; Mixed Amphetamine Salts