A randomized, double-blind, placebo-controlled study of atomoxetine in Japanese children and adolescents with attention-deficit/hyperactivity disorder

Journal of Child and Adolescent Psychopharmacology

Volumn 19, Issue 4, 2009, Pages 341-350

  Takahashi, Michihiro ^a   Takita, Yasushi ^a   Yamazaki, Kosuke ^b   Hayashi, Takashi ^c   Ichikawa, Hironobu ^d   Kambayashi, Yasuko ^e   Koeda, Tatsuya ^f   Oki, Junichi ^g   Saito, Kazuhiko ^h   Takeshita, Kenzo ⁱ   Allen, Albert J ^a  

^a ELI LILLY AND COMPANY   (United States)

^b MEJIRO UNIVERSITY   (Japan)

^c YAMAGUCHI PREFECTURAL UNIVERSITY   (Japan)

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

^e CHUO UNIVERSITY   (Japan)

^f TOTTORI UNIVERSITY   (Japan)

^g Asahikawa Kosei Hospital   (Japan)

^h 1 7 1 Kohnodai   (Japan)

ⁱ Fukuoka Social Medical Welfare University   (Japan)

Author keywords

[No Author keywords available]

Indexed keywords

ATOMOXETINE; PLACEBO;

ABDOMINAL PAIN; ADOLESCENT; ARTICLE; ATTENTION DEFICIT DISORDER; CHILD; CHILD PSYCHIATRY; CLINICAL TRIAL; CONTROL GROUP; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; ELECTROCARDIOGRAM; EVENING DOSAGE; FEMALE; HEADACHE; HEART RATE; HUMAN; JAPAN; JAPANESE; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MENTAL INSTABILITY; MORNING DOSAGE; MULTICENTER STUDY; NAUSEA; OPTIMAL DRUG DOSE; PATIENT COMPLIANCE; PRESCHOOL CHILD; QT INTERVAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RHINOPHARYNGITIS; SCHOOL CHILD; SEMI STRUCTURED INTERVIEW; SIDE EFFECT; SOMNOLENCE; SYSTOLIC BLOOD PRESSURE; TREATMENT DURATION; TREATMENT RESPONSE; VITAL SIGN; VOMITING; WEIGHT REDUCTION;

ADOLESCENT; AGE FACTORS; ASIAN CONTINENTAL ANCESTRY GROUP; ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; CHILD; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; PROPYLAMINES;

EID: 69549118772     PISSN: 10445463     EISSN: None     Source Type: Journal    
DOI: 10.1089/cap.2008.0154     Document Type: Article

References (30)

1. American Academy of Pediatrics, Committee on Quality Improvement and Subcommittee on Attention-Deficit/Hyperactivity Disorder. Clinical practice guideline: Diagnosis and evaluation of the child with attention-deficit/ hyperactivity disorder. Pediatrics 105:1158-1170, 2000.
2. th ed. (DSM-IV). Washington (DC): American Psychiatric Association, 1994.
3. th ed. Text Revision (DSM-IVTR). Washington (DC): American Psychiatric Association, 2000.
4. Biederman J, Heiligenstein JH, Faries DE, Galil N, Dittmann R, Emslie GJ, Kratochvil CJ, Laws HF, Schuh KJ: Efficacy of atomoxetine versus placebo in school-age girls with attention-deficit/hyperactivity disorder. Pediatrics 110:e75, 2002.
5. Broly F, Gaedigk A, Heim M, Eichelbaum M, Morike K, Meyer UA: Debrisoquine/sparteine hydroxylation genotype and phenotype: Analysis of common mutations and alleles of CYP2D6 in a European population. DNA Cell Biol 10:545-558, 1991.
6. Buitelaar JK, Danckaerts M, Gillberg C, Zuddas A, Becker K, Bouvard M, Fagan J, Gadoros J, Harpin V, Hazell P, Johnson M, Lerman-Sagie T, Soutullo CA, Wolanczyk T, Zeiner P, Fouche DS, Krikke-Workel J, Zhang S, Michelson D, Group: SIS: A prospective, multicenter, open-label assessment of atomoxetine in non-North American children and adolescents with ADHD. Eur Child Adolesc Psychiatry 13:249-257, 2004. (Pubitemid 39279157)
7. DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: Reliability and validity. In: ADHD Rating Scale-IV. Checklists, Norms, and Clinical Implications. New York (New York): Guilford Press, 1998, pp 28-42.
8. Guy W: ECDEU Assessment Manual for Psychopharmacology, revised. U.S. Department of Health, Education, and Welfare. Bethesda (Maryland), 1976.
9. Horai Y, Taga J, Ishizaki T, Ishikawa K: Correlations among the metabolic ratios of three test probes (metoprolol, debrisoquine and sparteine) for genetically determined oxidation polymorphism in a Japanese population. Br J Clin Pharmacol. 29:111-115, 1990. (Pubitemid 20130559)
10. Iwashima K, Yasui-Furukori N, Kaneda A, Saito M, Nakagami T, Sato Y, Kaneko S: No association between CYP2D6 polymorphisms and personality trait in Japanese. Br J Clin Pharmacol 64:96-99, 2007. (Pubitemid 46934423)
11. Japan Ministry of Health, Labour and Welfare; Pharmaceutical and Food Safety Bureau, Evaluation and Licensing Division: Notification 1026002 [In Japanese]. October 26, 2007.
12. Jasinski DR, Faries DE, Moore RJ, Schuh LM, Allen AJ: Abuse liability assessment of atomoxetine in a drug-abusing population. Drug Alcohol Depend 95:140-146, 2008.
13. Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N: 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 36:980-988, 1997. (Pubitemid 27272932)
14. Kelsey DK, Sumner CR, Casat CD, Coury DL, Quintana H, Saylor KE, Sutton VK, Gonzales J, Malcolm SK, Schuh KJ, Allen AJ: Once-daily atomoxetine treatment for children with attention-deficit/hyperactivity disorder, including an assessment of evening and morning behavior: A double-blind, placebo-controlled trial. Pediatrics 114:e1-e8, 2004.
15. Klassen AF, Miller A, Fine S: Health-related quality of life in children and adolescents who have a diagnosis of attention-deficit/hyperactivity disorder. Pediatrics 114:e541-e547, 2004. (Pubitemid 41655750)
16. Matza LS, Rentz AM, Secnik K, Swensen AR, Revicki DA, Michelson D, Spencer T, Newcorn JH, Kratochvil CJ: The link between health-related quality of life and clinical symptoms among children with attention-deficit hyperactivity disorder. J Dev Behav Pediatr 25:166-174, 2004. (Pubitemid 38960833)
17. Michelson D, Faries D, Wernicke J, Kelsey D, Kendrick K, Sallee FR, Spencer T, the Atomoxetine ADHD Study Group: Atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: A randomized, placebo-controlled, dose-response study. Pediatrics 108:e83, 2001.
18. Michelson D, Allen AJ, Busner J, Casat C, Dunn D, Kratochvil C, Newcorn J, Randy Sallee F, Bart Sangal R, Saylor K, West S, Kelsey D, Wernicke J, Trapp NJ, Harder D: Once-daily atomoxetine treatment for children and adolescents with attention-deficit/hyperactivity disorder: A randomized, placebo-controlled study. Am J Psychiatry 159:1896-1901, 2002.
19. Nakamura K, Goto F, Ray WA, McAllister CB, Jacqz E, Wilkinson GR, Branch RA: Interethnic differences in genetic polymorphism of debrisoquin and mephenytoin hydroxylation between Japanese and Caucasian populations. Clin Pharmacol Ther 38:402-408, 1985. (Pubitemid 16250313)
20. th Annual Meeting, 2002 (presentation).
21. National Institutes of Mental Health: Psychopharmacol Bull 21:839-943, 1985.
22. Ring BJ, Gillespie JS, Eckstein JA, Wrighton SA: Identification of the human cytochromes P450 responsible for atomoxetine metabolism. Drug Metab Dispos 30:319-323, 2002. (Pubitemid 34175024)
23. Sauer JM, Ponsler GD, Mattiuz EL, Long AJ, Witcher JW, Thomasson HR, Desante KA: Disposition and metabolic fate of atomoxetine hydrochloride. The role of CYP2D6 in human disposition and metabolism. Drug Metab Dispos 31:98-107, 2003.
24. Spencer T, Biederman J, Heiligenstein J, Wilens T, Faries D, Prince J, Faraone SV, Rea J, Witcher J, Zervas S: An open-label, dose-ranging study of atomoxetine in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol 11:251-265, 2001. (Pubitemid 32937637)
25. Spencer T, Heiligenstein JH, Biederman J, Faries DE, Kratochvil CJ, Keith Conners C, Potter WZ: Results from 2 proof-of-concept, placebo-controlled studies of atomoxetine in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry 63:1140-1147, 2002. (Pubitemid 36084059)
26. Wang Y, Zheng Y, Du Y, Song DH, Shin Y-J, Cho SC, Kim BN, Ahn DH, Marquez-Caraveo ME, Gao H, Williams DW, Levine LR: Atomoxetine versus methylphenidate in paediatric outpatients with attention deficit hyperactivity disorder: A randomized, double-blind comparison trial. Aust NZ J Psychiat 41:222-230, 2007. (Pubitemid 46705737)
27. Weiss M, Tannock R, Kratochvil C, Dunn D, Velez-Borras J, Thomason C, Tamura R, Kelsey D, Stevens L, Allen AJ: A randomized, placebo-controlled study of once-daily atomoxetine in the school setting in children with ADHD. J Am Acad Child Adolesc Psychiatry 44:647-655, 2005. (Pubitemid 40875359)
28. Williams DA: A test for differences between treatment means when several dose levels are compared with zero dose control. Biometrics 27:103-117, 1971.
29. Williams DA: The comparison of several dose levels with a zero dose control. Biometrics 28:519-531, 1972.
30. Yamazaki K, Kimura T, Koishi S, Asakura A, Ohya A, Hayashida H, Aki M, Sato M, Matsumoto T, Nakamura Y, Enseki Y, Kato Y, Atsumi M, Enomata J, Matsumoto H: Preparation of the ADHD Rating Scale-IV Japanese Version and its discriminative capability. Normative data of ADHD RS-IV: Japanese Version (Preparation of the diagnostic and treatment guideline for ADHD based on empirical research: research for psychiatric and neurological disorders funded by the Ministry of Health and Welfare in 2001) [in Japanese] Kambayashi Y. Chuui kekkan/Tadousei shougai no shindan • Chiryou gaidorain sakusei to sono jishouteki kenkyuu. Japan Ministry of Health and Welfare, Heisei 11-13 nendo kenkyuu houkokusho: 23-35, 2002.