title: A multi-centre, randomised, open-label study of atomoxetine compared with standard current therapy in UK children and adolescents with attention-deficit/hyperactivity disorder (ADHD).
abstract: OBJECTIVE
  To assess the broader efficacy (i.e., improvements in quality of life/functional outcomes) of atomoxetine compared with standard current therapy (SCT) in UK paediatric patients with ADHD and to explore clinician/parent/child perceptions of ADHD.
  
  
  METHODS
  A total of 201 patients with ADHD were randomised into this multi-centre, open-label study to receive atomoxetine (n = 104) or SCT (n = 97) for 10 weeks. Broader efficacy was assessed using the parent-rated Child Health and Illness Profile-Child Edition (CHIP-CE) total (global) t-score. Secondary outcome measures included the five CHIP-CE domains; parent-rated Family Burden of Illness Module (FBIM); investigator-rated ADHD-Rating Scale; investigator-rated Clinical Global Impression (CGI)-Severity/Improvement scales; and child-rated Harter Self-Perception Profile (HSPP).
  
  
  RESULTS
  Quality of life of children/adolescents with ADHD was extremely compromised at baseline (CHIP-CE total t-scores: atomoxetine, 23.2 +/- 12.2; SCT, 23.9 +/- 11.0), and improved during the 10-week study for both groups; the CHIP-CE score was statistically significantly higher for patients treated with atomoxetine (38.4 +/- 1.3) compared with SCT (30.8 +/- 1.3) at week 10 (p < 0.001). ADHD-RS, CGI-Severity, and CGI-Improvement scores were significantly different between the groups in favour of atomoxetine (p < 0.001). There was a statistically significant difference between the groups in the HSPP Social Acceptance domain in favour of atomoxetine, but not in the five other HSPP domains or FBIM total score. Atomoxetine was well-tolerated.
  
  
  CONCLUSIONS
  Results from this open-label trial show that atomoxetine is superior to SCT in addressing broader efficacy and functional outcomes in UK children/adolescents with ADHD. This study contributes to the understanding of broader efficacy in children with ADHD, and is timely in light of recent NICE guidance.
authors.affiliation: Dept Neurosciences, Eli Lilly and Co Ltd., Basingstoke, UK. suyash@suyashprasad.com
authors.forename: Suyash
authors.initials: S
authors.lastname: Prasad
authors.forename: Val
authors.initials: V
authors.lastname: Harpin
authors.forename: Lynne
authors.initials: L
authors.lastname: Poole
authors.forename: Harry
authors.initials: H
authors.lastname: Zeitlin
authors.forename: Saroj
authors.initials: S
authors.lastname: Jamdar
authors.forename: Kanagasabai
authors.initials: K
authors.lastname: Puvanendran
mesh_terms: D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D003000:Clonidine / Q000008:administration & dosage / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000627:therapeutic use; D009325:Nausea / Q000139:chemically induced; D011437:Propylamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D008774:Methylphenidate; D000069445:Atomoxetine Hydrochloride; D003000:Clonidine