Effectiveness of an Extended Release Stimulant Medication in Treating Preschool Children With ADHD
Information source: Baystate Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Disorder With Hyperactivity
Intervention: Sequence 1: XR-MAS then placebo (Drug); Sequence 2 Placebo then XR-MAS (Drug)
Phase: N/A
Status: Completed
Sponsored by: Baystate Medical Center Official(s) and/or principal investigator(s): John H. Fanton, MD, Principal Investigator, Affiliation: Baystate Medical Center
Summary
This study will evaluate the safety and effectiveness of extended release mixed amphetamine
salts in treating preschool children with attention deficit hyperactivity disorder.
Clinical Details
Official title: Placebo vs. Extended Release Stimulant Crossover Trial in Preschoolers With ADHD
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Composite Parent and Teacher Conners Rating Scale ScoreTolerance 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.
Eligibility
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
Locations and Contacts
Additional Information
Starting date: June 2008
Last updated: August 10, 2013
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