A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole for the treatment of acute manic or mixed episodes in Asian patients with bipolar i disorder (the AMAZE study)

World Journal of Biological Psychiatry

Volumn 15, Issue 2, 2014, Pages 113-121

  Kanba, Shigenobu ^a   Kawasaki, Hiroaki ^a   Ishigooka, Jun ^b   Sakamoto, Kaoru ^b   Kinoshita, Toshihiko ^c   Kuroki, Toshihide ^d  

^a KYUSHU UNIVERSITY   (Japan)

^b TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^c KANSAI MEDICAL UNIVERSITY   (Japan)

^d National Hospital Organization Hizen Psychiatric Center   (Japan)

Author keywords

Aripiprazole; Asian study; Bipolar I disorder; Efficacy; Safety

Indexed keywords

ANXIOLYTIC AGENT; ARIPIPRAZOLE; ATYPICAL ANTIPSYCHOTIC AGENT; CHOLINERGIC RECEPTOR BLOCKING AGENT; CREATINE KINASE; HYPNOTIC SEDATIVE AGENT; LAXATIVE; MOOD STABILIZER; NEUROLEPTIC AGENT; PROLACTIN; PIPERAZINE DERIVATIVE; PLACEBO; QUINOLONE DERIVATIVE;

ADULT; AKATHISIA; ARTICLE; ASIAN; BIPOLAR I DISORDER; BIPOLAR MANIA; BODY WEIGHT; CLINICAL GLOBAL IMPRESSION SCALE; CONSTIPATION; CONTROLLED STUDY; CREATINE KINASE BLOOD LEVEL; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EXTRAPYRAMIDAL SYMPTOM; FEMALE; HEADACHE; HUMAN; HYPERSALIVATION; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MIXED MANIA AND DEPRESSION; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; NAUSEA; PATIENT COMPLIANCE; POSITIVE AND NEGATIVE SYNDROME SCALE; PROLACTIN BLOOD LEVEL; PSYCHOPHARMACOTHERAPY; RANDOMIZED CONTROLLED TRIAL; RASH; RHABDOMYOLYSIS; TREATMENT RESPONSE; TREMOR; VOMITING; YOUNG MANIA RATING SCALE; ACUTE DISEASE; ASIA; ASIAN CONTINENTAL ANCESTRY GROUP; BIPOLAR DISORDER; CLINICAL TRIAL; MIDDLE AGED; PSYCHOLOGICAL RATING SCALE; TREATMENT OUTCOME;

ACUTE DISEASE; ADULT; ANTIPSYCHOTIC AGENTS; ASIA; ASIAN CONTINENTAL ANCESTRY GROUP; BIPOLAR DISORDER; DOUBLE-BLIND METHOD; HUMANS; MIDDLE AGED; PIPERAZINES; PLACEBOS; PSYCHIATRIC STATUS RATING SCALES; QUINOLONES; TREATMENT OUTCOME;

EID: 84893854296     PISSN: 15622975     EISSN: 18141412     Source Type: Journal    
DOI: 10.3109/15622975.2012.669047     Document Type: Article

References (29)

1. APA. 2000. Diagnostic and statistical manual of mental disorders. 4th ed. Text revision. Washington, DC: APA.
2. Barnes TR. 1989. A rating scale for drug-induced akathisia. Br J Psychiatry 154:672-676. (Pubitemid 19154942)
3. Burris KD, Molski TF, Xu C, Ryan E, Tottori K, Kikuchi T, et al. 2002. Aripiprazole, a novel antipsychotic, is a high-affi nity partial agonist at human dopamine D2 receptors. J Pharmacol Exp Ther 302(1):381-389. (Pubitemid 34680462)
4. Chong SA, Mythily, Remington G. 2003. Clinical characteristics and associated factors in antipsychotic-induced akathisia of Asian patients with schizophrenia. Schizophr Res 59(1):67-71. (Pubitemid 35284495)
5. El Mallakh RS, Vieta E, Rollin L, Marcus R, Carson WH, McQuade R. 2010. A comparison of two fi xed doses of aripiprazole with placebo in acutely relapsed, hospitalized patients with bipolar disorder I (manic or mixed) in subpopulations (CN138-007). Eur Neuropsychopharmacol 20(11):776-783.
6. Fagiolini A, Chengappa KN, Soreca I, Chang J. 2008. Bipolar disorder and the metabolic syndrome: causal factors, psychiatric outcomes and economic burden. CNS Drugs 22(8):655-669. (Pubitemid 351950097)
7. Goodwin GM. 2009. Evidence-based guidelines for treating bipolar disorder: revised second edition-recommendations from the British Association for Psychopharmacology. J Psychopharmacol 23(4):346-388.
8. Grunze H, Vieta E, Goodwin GM, Bowden C, Licht RW, Moller HJ, et al. 2009. The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2009 on the treatment of acute mania. World J Biol Psychiatry 10(2):85-116.
9. Guy W. 1976. Abnormal Involuntary Movement Scale (AIMS). In: ECDEU Assessment Manual for Psychopharmacology. US Department of Health, Education, and Welfare publication (ADM) 76-338. Rockville, MD: National Institute of Mental Health. p 534-537.
10. Inada T, Yagi G, Miura S. 2002. Extrapyramidal symptom profi les in Japanese patients with schizophrenia treated with olanzapine or haloperidol. Schizophr Res 57(2-3):227-238. (Pubitemid 35240025)
11. Jordan S, Koprivica V, Chen R, Tottori K, Kikuchi T, Altar CA. 2002. The antipsychotic aripiprazole is a potent, partial agonist at the human 5-HT(1A) receptor. Eur J Pharmacol 441(3):137-140. (Pubitemid 34626163)
12. Kay SR, Fiszbein A, Opler LA. 1987. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull 13(2):261-276. (Pubitemid 18039085)
13. Keck PE, Calabrese J, McQuade RD, Carson W, Carlson BX, Rollin LM, et al. 2006. A randomized, double-blind, placebocontrolled 26-week trial of aripiprazole in recently manic patients with bipolar I disorder. J Clin Psychiatry 67(4):626-637. (Pubitemid 43764240)
14. Keck PE, Calabrese JR, McIntyre RS, McQuade RD, Carson WH, Eudicone JM, et al. 2007. Aripiprazole monotherapy for maintenance therapy in bipolar I disorder: a 100-week, double-blind study versus placebo. J Clin Psychiatry 68(10):1480-1491. (Pubitemid 350073394)
15. Keck PE, Marcus R, Tourkodimitris S, Ali M, Liebeskind A, Saha A, et al. 2003. A placebo-controlled, double-blind study of the effi cacy and safety of aripiprazole in patients with acute bipolar mania. Am J Psychiatry 160(9):1651-1658. (Pubitemid 41079552)
16. Keck PE, Orsulak PJ, Cutler AJ, Sanchez R, Torbeyns A, Marcus RN, et al. 2009. Aripiprazole monotherapy in the treatment of acute bipolar I mania: a randomized, double-blind, placeboand lithium-controlled study. J Affect Disord 112(1-3):36-49.
17. Mahendran R, Hendricks M, Chan YH. 2010. Weight gain in Asian patients on second-generation antipsychotics. Ann Acad Med Singapore 39(2):118-121.
18. McIntyre RS, McCann SM, Kennedy SH. 2001. Antipsychotic metabolic effects: weight gain, diabetes mellitus, and lipid abnormalities. Can J Psychiatry 46(3):273-281. (Pubitemid 32423994)
19. Montgomery SA, Asberg M. 1979. A new depression scale designed to be sensitive to change. Br J Psychiatry 134:382-389. (Pubitemid 9136500)
20. Sachs G, Sanchez R, Marcus R, Stock E, McQuade R, Carson W, et al. 2006. Aripiprazole in the treatment of acute manic or mixed episodes in patients with bipolar I disorder: a 3-week placebo-controlled study. J Psychopharmacol 20(4):536-546. (Pubitemid 43875183)
21. Shapiro DA, Renock S, Arrington E, Chiodo LA, Liu LX, Sibley DR, et al. 2003. Aripiprazole, a novel atypical antipsychotic drug with a unique and robust pharmacology. Neuropsychopharmacol 28(8):1400-1411. (Pubitemid 41070874)
22. Simpson GM, Angus JW. 1970. A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl 212:11-19.
23. Stark AD, Jordan S, Allers KA, Bertekap RL, Chen R, Mistry Kannan T, et al. 2007. Interaction of the novel antipsychotic aripiprazole with 5-HT(1A) and 5-HT (2A) receptors: functional receptor-binding and in vivo electrophysiological studies. Psychopharmacology (Berlin) 190(3):373-382. (Pubitemid 46155646)
24. Suppes T, Dennehy EB, Hirschfeld RM, Altshuler LL, Bowden CL, Calabrese JR, et al. 2005. The Texas implementation of medication algorithms: update to the algorithms for treatment of bipolar I disorder. J Clin Psychiatry 66(7):870-886. (Pubitemid 41032829)
25. Vieta E, T'Joen C, McQuade RD, Carson WH Jr, Marcus RN, Sanchez R, et al. 2008. Effi cacy of adjunctive aripiprazole to either valproate or lithium in bipolar mania patients partially nonresponsive to valproate/lithium monotherapy: a placebocontrolled study. Am J Psychiatry 165(10):1316-1325.
26. White L, Harvey PD, Opler L, Lindenmayer JP. 1997. Empirical assessment of the factorial structure of clinical symptoms in schizophrenia. A multisite, multimodel evaluation of the factorial structure of the Positive and Negative Syndrome Scale. The PANSS Study Group. Psychopathology 30(5):263-274.
27. Yatham LN, Kennedy SH, Schaffer A, Parikh SV, Beaulieu S, O'Donovan C, et al. 2009. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2009. Bipolar Disord 11(3):225-255.
28. Young AH, Oren DA, Lowy A, McQuade RD, Marcus RN, Carson WH, et al. 2009. Aripiprazole monotherapy in acute mania: 12-week randomised placebo-and haloperidol-controlled study. Br J Psychiatry 194(1):40-48.
29. Young RC, Biggs JT, Ziegler VE, Meyer DA. 1978. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 133:429-435. (Pubitemid 9006756)