title: Long-term tolerability and effectiveness of once-daily mixed amphetamine salts (Adderall XR) in children with ADHD.
abstract: OBJECTIVE
  To evaluate the long-term tolerability and effectiveness of extended-release mixed amphetamine salts (MAS XR; Adderall XR) in children with attention-deficit/hyperactivity disorder (ADHD).
  
  
  METHODS
  This was a 24-month, multicenter, open-label extension of TWO placebo-controlled studies of MAS XR in children with ADHD aged 6 to 12 years. Subjects (N=568) began treatment with MAS XR 10 mg once daily, with 10-mg weekly dose increases to optimal effectiveness (maximum dose, 30 mg/d). Effectiveness was assessed with analysis of quarterly Conners Global Index Scale, Parent version (CGIS-P) scores. Tolerability was assessed by monitoring adverse events (AEs), vital signs, physical examinations, and serial laboratory tests.
  
  
  RESULTS
  Significant improvements (>30%, p < .001) in CGIS-P scores were maintained during long-term treatment. Treatment was well tolerated, and most AEs were mild. The most frequently reported drug-related AEs included anorexia, insomnia, and headache. The incidence of drug-related AEs increased with increasing MAS XR dose, suggesting a dose relationship. Changes in laboratory values and vital signs were modest and not clinically meaningful.
  
  
  CONCLUSIONS
  In children with ADHD, once-daily 10 mg-30 mg MAS XR was well tolerated and significant behavioral improvements were consistently maintained during 24 months of treatment.
authors.affiliation: Division of Child and Adolescent Psychiatry, UCLA Neuropsychiatric Institute, Los Angeles, CA, USA. jmcgough@mednet.ucla.edu
authors.forename: James J
authors.initials: JJ
authors.lastname: McGough
authors.forename: Joseph
authors.initials: J
authors.lastname: Biederman
authors.forename: Sharon B
authors.initials: SB
authors.lastname: Wigal
authors.forename: Frank A
authors.initials: FA
authors.lastname: Lopez
authors.forename: James T
authors.initials: JT
authors.lastname: McCracken
authors.forename: Thomas
authors.initials: T
authors.lastname: Spencer
authors.forename: Yuxin
authors.initials: Y
authors.lastname: Zhang
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Tulloch
mesh_terms: D000662:Amphetamines / Q000008:administration & dosage* / Q000009:adverse effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008134:Long-Term Care; D008297:Male; D010552:Personality Assessment; D016896:Treatment Outcome
chemical_list: C090411:Adderall; D000662:Amphetamines; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations