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

Not Applicable

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Drug: Sequence 2 Placebo then XR-MAS

• Registration Number: NCT00712699
• Lead Sponsor: Baystate Medical Center

Brief 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-08
• Study First Posted: 2008-07-10
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2013-08
• Disposition First Submitted: 2013-08-10
• Disposition First Submitted QC: 2013-08-10
• Last Update Submitted: 2013-08-10
• Disposition First Posted: 2013-08-23
• Last Update Posted: 2013-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Living at home for at least 6 months with parent or caregiver
• Enrolled in a structured school setting at least 2 half days a week with a minimum of 7 peers
• Full Scale Intelligence Quotient (FSIQ) of 70 or greater OR 72 or greater if bilingual
• Best estimate diagnosis based on clinical interview, Diagnostic Interview Schedule for Children, Child Behavior Checklist, and rating scales scores
• Symptoms present for at least 9 months
• Meets severity criteria for Clinical Global Impression-Severity with score of greater than or equal to 4 and Clinical Global Assessment Scale score of greater than or equal to 55
• Parent/caregiver can commit to 6 weekly sessions, including initial screening exams
• If on current psychotropic medication, will undergo a washout period of at least 3 days before study entry
• Not currently receiving psychotherapy or started psychotherapy within 30 days of study entry

Exclusion Criteria

• Previous nonresponse to mixed amphetamine salts (defined as 2 weeks of persistent symptoms in spite of doses greater than or equal to 15 mg per day)
• Diagnosis of language-based or cognitive delay of more than 2 standard deviations below same-aged peers or diagnosis of mental retardation
• Pervasive developmental disorder or autism
• Significant developmental disorder (e.g., blindness, deafness, cerebral palsy, epilepsy, psychosis)
• Taking another psychotropic medication that cannot be discontinued
• Serious psychiatric disorder (e.g., bipolar, suicidality, tic disorder)
• Actively taking medication for certain medical conditions (e.g., hypertension, structural cardiac condition, glaucoma, hyperthyroidism)
• Allergy to mixed amphetamine salts
• History of physical, sexual, or emotional abuse that is clinically significant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1: XR-MAS then placebo	Sequence 2 Placebo then XR-MAS	Depending on whether 1) child has had previous medication trial or 2) is on psychotropic medication at time of screening, children will either enter the washout period of 3 days before extended release mixed amphetamine salts (XR-MAS) or placebo (PBO) is initiated or proceed directly to the active treatment sequence they were randomized to. Participants randomized to Sequence 1 first receive treatment with XR-MAR for 3 weeks and then placebo for 3 weeks. Flexible, forced dosing will start at 5 mg/day for the first week, increase to 10 mg/day for the second week and continue to 15 mg/day on the third week. No washout period otherwise occurs (XR-MAS is not clinically suspected to have lingering effects beyond initial dosing/day of administration), including the crossover week to PBO.
Sequence 2 Placebo then XR-MAS	Sequence 2 Placebo then XR-MAS	Depending on whether 1) child has had previous medication trial or 2) is on psychotropic medication at time of screening, children will either enter the washout period of 3 days before extended release mixed amphetamine salts (XR-MAS) or placebo (PBO) is initiated or proceed directly to the active treatment sequence they were randomized to. Participants randomized to Sequence 2 will first receive treatment with PBO for 3 weeks and then XR-MAS for 3 weeks. Flexible, forced dosing will start at 5 mg/day for the first week, increase to 10 mg/day for the second week and continue to 15 mg/day on the third week. No washout period (stimulants are not clinically suspected to have lingering effects beyond initial dosing/day of administration)otherwise occurs, including the crossover week to XR-MAS.

Primary Outcome Measures

Name	Time	Method
Composite Parent and Teacher Conners Rating Scale Score	Measured weekly for 6 weeks
Tolerance of extended release mixed amphetamine salts	Measured weekly for 6 weeks

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression- Improvement Score	Measured weekly for 6 weeks