NCT00712699

Effectiveness of an Extended Release Stimulant Medication in Treating Preschool Children With ADHD

Placebo vs. Extended Release Stimulant Crossover Trial in Preschoolers With ADHD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Baystate Medical Center · Academic / Other
• Sex: All
• Age: 36 Months – 66 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Disorder With Hyperactivity

Interventions

Type	Name	Description
DRUG	Sequence 1: XR-MAS then placebo	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.
DRUG	Sequence 2 Placebo then XR-MAS	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.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-07-10
• Last updated: 2013-08-23