Efficacy and Safety of Atomoxetine Hydrochloride in Asian Adults With ADHD: A Multinational 10-Week Randomized Double-Blind Placebo-Controlled Asian Study

Journal of Attention Disorders

Volumn 21, Issue 2, 2017, Pages 100-109

  Goto, Taro ^a   Hirata, Yuko ^a   Takita, Yasushi ^a   Trzepacz, Paula T ^a,b   Allen, Albert J ^a   Song, Dong Ho ^c   Gau, Susan Shur Fen ^d   Ichikawa, Hironobu ^e   Takahashi, Michihiro ^a,f  

^a ELI LILLY AND COMPANY   (United States)

^b INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c Yonsei University   (South Korea)

^d NATIONAL TAIWAN UNIVERSITY   (Taiwan)

^e TOKYO METROPOLITAN CHILDREN'S MEDICAL CENTER   (Japan)

^f Terauchi Takahashi Psychiatric Clinic   (Japan)

Author keywords

adult ADHD; Asian population; atomoxetine; executive function; quality of life

Indexed keywords

ADRENERGIC RECEPTOR AFFECTING AGENT; ATOMOXETINE;

ADULT; ASIAN CONTINENTAL ANCESTRY GROUP; ATTENTION DEFICIT DISORDER; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG ADMINISTRATION; DRUG EFFECTS; DRUG SUBSTITUTION; ETHNOLOGY; EXECUTIVE FUNCTION; FEMALE; HUMAN; JAPAN; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SOUTH KOREA; TAIWAN; TREATMENT OUTCOME;

ADRENERGIC UPTAKE INHIBITORS; ADULT; ASIAN CONTINENTAL ANCESTRY GROUP; ATOMOXETINE HYDROCHLORIDE; ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG SUBSTITUTION; EXECUTIVE FUNCTION; FEMALE; HUMANS; JAPAN; MALE; QUALITY OF LIFE; REPUBLIC OF KOREA; TAIWAN; TREATMENT OUTCOME;

EID: 85008668690     PISSN: 10870547     EISSN: 15571246     Source Type: Journal    
DOI: 10.1177/1087054713510352     Document Type: Article

References (35)

1. Adler L. A., Cohen J., (2004). Diagnosis and evaluation of adults with attention-deficit/hyperactivity disorder. Psychiatric Clinics of North America, 27, 187-201.
2. Adler L. A., Liebowitz M., Kronenberger W., Qiao M., Rubin R., Hollandbeck M...Durell T., (2009). Atomoxetine treatment in adults with attention-deficit/hyperactivity disorder and comorbid social anxiety disorder. Depression and Anxiety, 26, 212-221.
3. Adler L. A., Spencer T., Brown T. E., Holdnack J., Saylor K., Schuh K... Kelsey D., (2009). Once-daily atomoxetine for adult attention-deficit/hyperactivity disorder: A 6-month, double-blind trial. Journal of Clinical Psychopharmacology, 29, 44-50.
4. American Psychiatric Association. (2000). Diagnostic and statistical manual of mental disorders (4th ed., text rev.). Washington, DC: Author.
5. Barkley R. A., (1998). Attention deficit hyperactivity disorder: A handbook for diagnosis and treatment (2nd ed.). New York, NY: Guilford.
6. Barkley R. A., Murphy K. R., Dupaul G. I., Bush T., (2002). Driving in young adults with attention deficit hyperactivity disorder: Knowledge, performance, adverse outcomes, and the role of executive functioning. Journal of the International Neuropsychological Society, 8, 655-672.
7. Biederman J., Faraone S. V., Spencer T. J., Mick E., Monuteaux M. C., Aleardi M., (2006). Functional impairments in adults with self-reports of diagnosed ADHD: A controlled study of 1001 adults in the community. Journal of Clinical Psychiatry, 67, 524-540.
8. Biederman J., Monuteaux M. C., Doyle A. E., Seidman L. J., Wilens T. E., Ferrero F...Faraone S. V., (2004). Impact of executive function deficits and attention-deficit/hyperactivity disorder (ADHD) on academic outcomes in children. Journal of Consulting and Clinical Psychology, 72, 757-766.
9. Brod M., Johnston J., Able S., Swindle R., (2006). Validation of the Adult Attention-Deficit/Hyperactivity Disorder Quality-of-Life Scale (AAQoL): A disease-specific quality-of-life measure. Quality of Life Research, 15, 117-129.
10. Brod M., Perwien A., Adler L., Spencer T., Johnston J., (2005). Conceptualization and assessment of quality of life for adults with attention-deficit/hyperactivity disorder. Primary Psychiatry, 12(6), 58-64.
11. Brown T. E., (2008). ADD/ADHD and impaired executive function in clinical practice. Current Psychiatry Reports, 10, 407-411.
12. Brown T. E., Landgraf J. M., (2010). Improvements in executive function correlate with enhanced performance and functioning and health-related quality of life: Evidence from 2 large, double-blind, randomized, placebo-controlled trials in ADHD. Postgraduate Medicine, 122(5), 42-51.
13. Conners C. K., Erhardt D., Sparrow E., (1999). Conners’ Adult ADHD Rating Scales (CAARS). New York, NY: Multi-Health Systems.
14. Faraone S. V., Biederman J., Spencer T., Wilens T., Seidman L. J., Mick E., Doyle A. E., (2000). Attention-deficit/hyperactivity disorder in adults: An overview. Biological Psychiatry, 48, 9-20.
15. Gau S. S., Huang Y. S., Soong W. T., Chou M. C., Chou W. J., Shang C. Y...Lee P., (2007). A randomized, double-blind, placebo-controlled clinical trial on once-daily atomoxetine in Taiwanese children and adolescents with attention-deficit/hyperactivity disorder. Journal of Child and Adolescent Psychopharmacology, 17, 447-460.
16. Guy W., (1976). ECDEU Assessment Manual for Psychopharmacology (Revised). Bethesda, MD: U.S. Department of Health, Education and Welfare.
17. Ingelman-Sundberg M., Sim S. C., Gomez A., Rodriguez-Antona C., (2007). Influence of cytochrome P450 polymorphisms on drug therapies: Pharmacogenetic, pharmacoepigenetic and clinical aspects. Pharmacology & Therapeutics, 116, 496-526.
18. Kessler R. C., Adler L., Barkley R., Biederman J., Conners C. K., Demler O...Zaslavsky A. M., (2006). The prevalence and correlates of adult ADHD in the United States: Results from the National Comorbidity Survey Replication. American Journal of Psychiatry, 163, 716-723.
19. Lara C., Fayyad J., de Graaf R., Kessler R. C., Aguilar-Gaxiola S., Angermeyer M...Sampson N., (2009). Childhood predictors of adult attention-deficit/hyperactivity disorder: Results from the World Health Organization World Mental Health Survey Initiative. Biological Psychiatry, 65, 46-54.
20. Matsui A., Azuma J., Witcher J. W., Long A. J., Sauer J. M., Smith B. P...Nakano M., (2012). Pharmacokinetics, safety, and tolerability of atomoxetine and effect of CYP2D6*10/*10 genotype in healthy Japanese men. The Journal of Clinical Pharmacology, 52, 388-403.
21. Matza L. S., Johnston J. A., Faries D. E., Malley K. G., Brod M., (2007). Responsiveness of the Adult Attention-Deficit/Hyperactivity Disorder Quality of Life Scale (AAQoL). Quality of Life Research, 16, 1511-1520.
22. Michelson D., Adler L., Spencer T., Reimherr F. W., West S. A., Allen A. J...Milton D., (2003). Atomoxetine in adults with ADHD: Two randomized, placebo-controlled studies. Biological Psychiatry, 53, 112-120.
23. National Institute of Mental Health. (1985). CGI (Clinical Global Impression) Scale—NIMH. Psychopharmacology Bulletin, 21(4), 839-844.
24. Ni H. C., Lin Y. J., Gau S. S., Huang H. C., Yang L. K., (2016). An open-label, randomized trial of methylphenidate and atomoxetine treatment in adults with ADHD. Journal of Attention Disorders, 21, 27-39. doi:10.1177/ 1087054713476549
25. Ni H. C., Shang C. Y., Gau S. S., Lin Y. J., Huang H. C., Yang L. K., (2013). A head-to-head randomized clinical trial of methylphenidate and atomoxetine treatment for executive function in adults with attention-deficit hyperactivity disorder. International Journal of Neuropsychopharmacology, 16, 1959-1973.
26. Nigg J. T., Stavro G., Ettenhofer M., Hambrick D. Z., Miller T., Henderson J. M., (2005). Executive functions and ADHD in adults: Evidence for selective effects on ADHD symptom domains. Journal of Abnormal Psychology, 114, 706-717.
27. Park S., Cho M. J., Chang S. M., Jeon H. J., Cho S. J., Kim B. S...Hong J. P., (2011). Prevalence, correlates, and comorbidities of adult ADHD symptoms in Korea: Results of the Korean epidemiologic catchment area study. Psychiatry Research, 186, 378-383.
28. Roth R. M., Isquith P. K., Gioia G. A., (2005). Behavior Rating Inventory of Executive Function–Adult Version. Lutz, FL: Psychological Assessment Resources.
29. Royall D. R., Chiodo L. K., Mouton C., Polk M. J., (2007). Cognitive predictors of mortality in elderly retirees: Results from the freedom house study. American Journal of Geriatric Psychiatry, 15, 243-251.
30. Shimizu T., Ochiai H., Asell F., Shimizu H., Saitoh R., Hama Y...Ozawa N., (2003). Bioinformatics research on inter-racial difference in drug metabolism I: Analysis on frequencies of mutant alleles and poor metabolizers on CYP2D6 and CYP2C19. Drug Metabolism and Pharmacokinetics, 18, 48-70.
31. Spencer T., Biederman J., Wilens T. E., Faraone S. V., (1998). Adults with attention-deficit/hyperactivity disorder: A controversial diagnosis. Journal of Clinical Psychiatry, 59(Suppl. 7), 59-68.
32. Takahashi M., Takita Y., Goto T., Ichikawa H., Saito K., Matsumoto H., Tanaka Y., (2011). An open-label, dose-titration tolerability study of atomoxetine hydrochloride in Japanese adults with attention-deficit/hyperactivity disorder. Psychiatry and Clinical Neurosciences, 65, 55-63.
33. Wender P. H., Wolf L. E., Wasserstein J., (2001). Adults with ADHD: An overview. Annals of the New York Academy of Sciences, 931, 1-16.
34. Westfall P. H., Krishen A., (2001). Optimally weighted, fixed sequence and gatekeeping multiple testing procedures. Journal of Statistical Planning and Inference, 99, 25-40.
35. Willcutt E. G., Doyle A. E., Nigg J. T., Faraone S. V., Pennington B. F., (2005). Validity of the executive function theory of attention-deficit/hyperactivity disorder: A meta-analytic review. Biological Psychiatry, 57, 1336-1346.