Effectiveness of an Extended Release Stimulant Medication in Treating Preschool Children With Attention Deficit Hyperactivity Disorder (The APS Study)

Condition(s) targeted: Attention Deficit Disorder With Hyperactivity

Intervention: Extended release mixed amphetamine salts (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: National Institute of Mental Health (NIMH)

Official(s) and/or principal investigator(s):
John H. Fanton, MD, Principal Investigator, Affiliation: Baystate Medical Center

Overall contact:
John H. Fanton, MD, Phone: 413-794-7492, Email: john.fanton@bhs.org

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome:

Composite Parent and Teacher Conners Rating Scale Score

Tolerance of extended release mixed amphetamine salts

Secondary outcome: Clinical Global Impression- Improvement Score

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.

Minimum age: 36 Months. Maximum age: 66 Months. Gender(s): Both.

Criteria:

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

John H. Fanton, MD, Phone: 413-794-7492, Email: john.fanton@bhs.org

Baystate Medical Center, Springfield, Massachusetts 01199, United States; Recruiting
John H. Fanton, MD, Principal Investigator

Starting date: June 2008
Ending date: August 2009
Last updated: March 12, 2009