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)^*

References

• National Institute for Health and Clinical Excellence. Methyl-phenidate, atomoxetine and dexamfetamine for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Review of Technology Appraisal 13; Technology Appraisal 98, March 2006
   Google Scholar
• Hechtman L. Assessment and diagnosis of attention-deficit/ hyperactivity disorder. Child Adolesc Psychiatr Clin N Am 2000;9481–98
   Web of Science ®Google Scholar
• Johnson C, Mash EJ. Families of children with ADHD: review and recommendations for future research. Clin Child Fam Psychol Rev 2001;4:183–207
   PubMed Web of Science ®Google Scholar
• McClure A, Prasad S, Poole L, et al. Functional outcomes of children with attention deficit hyperactivity disorder in the UK. Arch Dis Child 2005;90(Suppl II):A48–A50
   Google Scholar
• Klein RG, Mannuzza S. Long-term outcome of hyperactive children: a review. J Am Acad Child Adolesc Psychiatry 1991;30:383–7
   PubMed Web of Science ®Google Scholar
• Harpin VA. The effect of ADHD on the life of an individual, their family, and community from preschool to adult life. Arch Dis Child 2005;90 Suppl 1:i2–7
   PubMed Web of Science ®Google Scholar
• Achenbach TM, McConaughy SH, Howell CT. Child/adolescent behavioral and emotional problems: implications of cross- informant correlations for situational specificity. Psychol Bull 1987;101:213–32
   Google Scholar
• Sawyer M, Antoniou G, Toogood I, et al. A comparison of parent and adolescent reports describing the health related quality of life of adolescents treated for cancer. Int J Cancer Supp 1999;12:39–45
   PubMedGoogle Scholar
• Prasad S, Poole L. Assessing quality of life in children and adolescents with ADHD: SUNBEAM, an open comparative study of atomoxetine and standard therapy. Patient Reported Outcomes Newsletter 2006;36:16–19
   Google Scholar
• Prasad S. A new paradigm for developing drugs in children: atomoxetine as a model. Arch Dis Child 2005;90 Suppl 1:i13–16
   PubMed Web of Science ®Google Scholar
• Swanson JM, Kraemer HC, Hinshaw SP, et al. Clinical relevance of the primary findings of the MTA: success rates based on severity of ADHD and ODD symptoms at the end of treatment. J Am Acad Child Adolesc Psychiatry 2001;40:168–79
   PubMed Web of Science ®Google Scholar
• Barkley RA, McMurray MB, Edelbrock CS, et al. Side effects of methylphenidate in children with attention deficit hyperactivity disorder: a systemic, placebo-controlled evaluation. Pediatrics 1990;86:184–92
   PubMed Web of Science ®Google Scholar
• Swanson J. Compliance with stimulants for attention-deficit/ hyperactivity disorder: issues and approaches for improvement. CNS Drugs 2003;17:117–31
   PubMed Web of Science ®Google Scholar
• Kratochvil CJ, Vaughan BS, Harrington MJ, et al. Atomoxetine: a selective noradrenaline reuptake inhibitor for the treatment of attention-deficit/hyperactivity disorder. Expert Opin Pharmacother 2003;4:1165–74
   PubMed Web of Science ®Google Scholar
• Summary of Product Characteristics. Strattera Atomoxetine HCl. Eli Lilly and Company, 2006. Available from: http://www.medicines.org.uk/searchresult.aspx?search=atomoxetine [Accessed 2 August 2006]
   Google Scholar
• Mosholder AD. Psychiatric adverse events in Attention-Deficit/ Hyperactivity Disorder (ADHD) clinical trials. Food and Drugs Administration, Pediatric Advisory Committee March 22, 2006. Available at: http://www.fda.gov/ohrms/dockets/ac/06/slides/2006–4210s_14_Mosholder_Psychiatric%20Adverse%20 Events_files/frame.htm [Accessed on: 20 July 2006]
   Google Scholar
• Kratochvil CJ, Heiligenstein JH, Dittmann R, et al. Atomoxetine and methylphenidate treatment in children with ADHD: a prospective, randomised, open-label trial. J Am Acad Child Adolesc Psychiatry 2002;41:776–84
   PubMed Web of Science ®Google Scholar
• Michelson D, Faries D, Wernicke J, et al. Atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: a randomized, Placebo-controlled, dose- response study. Pediatrics 2001;108(5):E83
   PubMed Web of Science ®Google Scholar
• Michelson D, Allen AJ, Busner J, et al. Once-daily atomoxetine treatment for children and adolescents with attention-deficit/ hyperactivity disorder: a randomized, placebo-controlled study. Am J Psychiatry 2002;159:1896–901
   PubMed Web of Science ®Google Scholar
• Michelson D, Buitelaar JK, Danckaerts M, et al. Relapse prevention in pediatric patients with ADHD treated with atomoxetine: a randomized, double-blind, placebo-controlled study. J Am Acad Child Adolesc Psychiatry 2004;43:896–904
   PubMed Web of Science ®Google Scholar
• Rebok G, Riley AW, Forrest C, et al. Elementary school-aged children’s reports of their health: a cognitive interviewing study. Qual Life Res 2001;10:59–70
   PubMed Web of Science ®Google Scholar
• Riley AW, Forrest CB, Starfield B, et al. The parent report form of the CHIP-Child Edition. Reliability and Validity. Med Care 2004;42:210–20
   PubMed Web of Science ®Google Scholar
• Riley AW, Forrest CB, Starfield B, et al. A taxonomy of adolescent health need: reliability and validity of the adolescent health and illness profiles. Med Care 1998;36:1237–48
   PubMed Web of Science ®Google Scholar
• Starfield B, Riley A, Ensminger M, et al. Manual for the Child Health and Illness Profile – Child Edition (CHIP-CE). Baltimore, MD: The Johns Hopkins University, 2000
   Google Scholar
• Central Office for Research and Ethics Committees. Available at: http://www.corec.org.uk [Accessed on: 18 September 2006]
   Google Scholar
• American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 4th edition. Text revised. Washington DC: American Psychiatric Association. 2000
   Google Scholar
• Kaufman J, Birmaher B, Brent D, et al. Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. J Am Acad Child Adolesc Psychiatry 1997;36:980–8
   PubMed Web of Science ®Google Scholar
• Du Paul GJ. ADHD Rating Scale IV checklist, norms and clinical interpretations. New York, NY: The Guildford Press, 1998
   Google Scholar
• Riley A, Chan K, Prasad S, et al. A Global Measure of Child Health Related Quality of Life: Reliability and Validity of the CHIP-CE Global Score. J Outcomes Res (submitted for publication)
   Google Scholar
• Family Burden of Illness Module. Data on file, Eli Lilly & Co., Basingstoke, UK
   Google Scholar
• Faries DE, Yalsin I, Harder D, et al. Validation of the ADHD rating scale as a clinician administered and scored instrument. J Attent Disord 2002;5:107–15
   Google Scholar
• Guy W. ECDU Assessment Manual for Psychopharmacology, Revised. Bethesda (MD): US Dept of Health, Education and Welfare, 1976
   Google Scholar
• National Institute of Mental Health. Psychopharmacol Bull 1985;21:839–943
   Web of Science ®Google Scholar
• Harter S. Manual for the Self-Perception Profile for Children. Denver: University of Denver Press. 1985
   Google Scholar
• Zhang S, Faries DE, Vowles M, et al. ADHD Rating Scale IV: psychometric properties from a multinational study as a clinician-administered instrument. Int J Methods Psychiatr Res 2005;14:186–201
   PubMed Web of Science ®Google Scholar
• Michelson D. Results from a double blind study of atomoxetine, OROS methylphenidate and placebo. 51st Ann Mtg Am Acad Child Adolesc Psychiatry, Washington DC, USA, October 19–24, 2004. Sci Proc 2004;20D:49
   Google Scholar
• Whincup PH, Gilg JA, Odoki K, et al. Age of Menarche in contemporary British Teenagers: survey of girls born between 1982 and 1986. Brit Med J 2001;322:1095–6
   PubMed Web of Science ®Google Scholar
• Barton J. Atomoxetine: a new pharmacotherapeutic approach in the management of attention-deficit/hyperactivity disorder. Arch Dis Child 2005;90 Suppl 1:i26–9
   PubMed Web of Science ®Google Scholar
• Banaschewski T, Coghill D, Santosh P, et al. Long-acting medications for the hyperkinetic disorders. A systematic review and European Treatment guidelines. Eur Child Adolesc Psychiatry 2006; May 5 (Epub ahead of print)
   Google Scholar
• Kelsey DK, Sumner CR, Casat CD, et al. Once-daily atomoxetine treatment for children and adolescents with Attention-Deficit/Hyperactivity Disorder, including an assessment of evening and morning behavior: a double-blind, placebo-controlled trial. Pediatrics 2004;114:e1–e8. URL: http://www.pediatrics.org/ cgi/content/full/114/1/e1
   Google Scholar
• The MTA Cooperative Group. A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. The MTA Cooperative Group. Multimodal Treatment Study of Children with ADHD. Arch Gen Psychiatry 1999;56:1073–86
   PubMed Web of Science ®Google Scholar
• Prasad S, Poole L, Sonuga-Barke E. Atomoxetine in the treatment of attention-deficit/hyperactivity disorder in children and adolescents: effects on broader efficacy. Oral presentation at the 16th World Congr Int Assoc Child Adolesc Psychiatry Allied Professions (IACAPAP) August 22–26, 2004, Berlin, Germany
   Google Scholar
• Prasad S, Ralston S, Coghill D, et al. Preliminary findings from ADORE UK: symptom severity, treatments, and burden of illness. Dev Med Child Neurol 2004;46:20–1
   Google Scholar
• Ralston SJ, Lorenzo MJM. ADORE – Attention-Deficit/Hyperactivity Disorder Observational Research in Europe. Eur Child Adolesc Psychiatry 2004;13 (Suppl 1):1/36–1/42
   Google Scholar
• Matza LS, Secnik K, Mannix S, et al. Parent-proxy EQ-5D ratings of children with attention-deficit hyperactivity disorder in the US and the UK, Pharmacoeconomics 2005;23: 777–90
   Google Scholar
• Escobar R, Soutullo CA, Hervas A, et al. Worse quality of life for children with newly diagnosed attention-deficit/ hyperactivity disorder, compared with asthmatic and healthy children. Pediatrics 2005;116:e364–9
   PubMed Web of Science ®Google Scholar
• Steer CR. Managing attention deficit/hyperactivity disorder: unmet needs and future directions. Arch Dis Child 2005;90 Suppl 1:i19–25
   PubMed Web of Science ®Google Scholar
• Eli Lilly and Company (Source). Study suggests atomoxetine significantly improved functioning in children with both ADHD and anxiety disorders. Doctors Guide, Personal Edition. Toronto, Canada; May 31, 2006
   Google Scholar
• Sumner C, Donnelly C, Lopez FA, et al. Atomoxetine treatment for pediatric patients with ADHD and comorbid anxiety. 158th Ann Meeting Am Psych Assoc May 21–26, 2005, Atlanta, GA.
   Google Scholar
• Summary of Product Characteristics Ritalin Methylphenidate Hydrochloride. Novartis, 2005. Available from: http://www.medicines.org.uk/searchresult.aspx?search=ritalin [Accessed on 2 Aug 2006]
   Google Scholar
• Tannock R, Ickowicz A, Schachar R. Differential effects of methylphenidate on working memory in ADHD children with and without comorbid anxiety. J Am Acad Child Adolesc Psychiatry 1995;34:886–96
   Google Scholar
• Gadow KD, Nolan EE, Sverd J, et al. Anxiety and depression symptoms and response to methylphenidate in children with attention-deficit hyperactivity disorder and tic disorder. J Clin Psychopharmacol 2002;22:267–74
   PubMed Web of Science ®Google Scholar
• Allen AJ, Kurlan RM, Gilbert DL, et al. Atomoxetine treatment in children and adolescents with ADHD and comorbid tic disorders. Neurology 2005;65:1941–9
   PubMed Web of Science ®Google Scholar
• Shatkin JP. Atomoxetine for the treatment of pediatric nocturnal enuresis. J Child Adolesc Psychopharmacol 2004;14:443–7
   PubMed Web of Science ®Google Scholar
• Choonara I. Improving Children’s Medicines. Arch Dis Child 2006;91:550–1
   PubMed Web of Science ®Google Scholar
• EurActiv. Medicines for children. Health & Pharma. Updated on 2 June 2006. Available from: http://www.euractiv.com/en/health/medicines-children/article-132015 [Accessed on: 26 July 2006]
   Google Scholar
• Medicines and Healthcare Products Control Agency (MHRA)/Department of Health Strategy on Medicines for children. Available from: http://www.mhra.gov.uk/home/ idcplg?IdcService=SS_GET_PAGE&nodeId=132 [Accessed on: 26 July 2006]
   Google Scholar