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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baystate Medical Center
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Adderall; Amphetamine; Central Nervous System Stimulants

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