Aripiprazole augmentation to antidepressant therapy in Japanese patients with major depressive disorder: A randomized, double-blind, placebo-controlled study (ADMIRE study)

JOURNAL OF AFFECTIVE DISORDERS

卷:151

Article

Kamijima, Kunitoshi¹  Higuchi, Teruhiko²  Ishigooka, Jun³  Ohmori, Tetsuro⁴  Ozaki, Norio⁵  Kanba, Shigenobu⁶  Kinoshita, Toshihiko⁷  Koyama, Tsukasa⁸ 

[1] Int Univ Hlth & Welf, Dept Social Serv & Healthcare Management, Otawara, Tochigi 3248501, Japan

[2] Natl Ctr Neurol & Psychiat, Kodaira, Tokyo, Japan

[3] Tokyo Womens Med Univ, Dept Psychiat, Tokyo, Japan

[4] Univ Tokushima, Sch Med, Dept Psychiat, Inst Hlth Biosci, Tokushima 770, Japan

[5] Nagoya Univ, Grad Sch Med, Dept Psychiat, Nagoya, Aichi 4648601, Japan

[6] Kyushu Univ, Grad Sch Med Sci, Dept Neuropsychiat, Fukuoka 812, Japan

[7] Kansai Med Univ, Dept Neuropsychiat, Osaka, Japan

[8] Ohyachi Hosp Clin Res Ctr, Sapporo, Hokkaido, Japan

关键词: Aripiprazole;    Major depressive disorder;    Japanese;    antipsychotic;    augmentation therapy;   

DOI  :  10.1016/j.jad.2013.07.035

来源: Elsevier

【 摘 要 】

Objective: This randomized, placebo-controlled study evaluated the efficacy and safety of a fixed dose (3 mg/day) and flexible dose (3-15 mg/day) schedule of aripiprazole as augmentation therapy in Japanese patients with inadequate response to antidepressant therapy (ADT). Method: During an 8-week prospective treatment phase, patients experiencing a major depressive episode received clinicians' choice of ADT. Subjects with inadequate response to ADT were randomized to receive adjunctive treatment with placebo (n=195), fixed dose aripiprazole (n=197) or flexible dose aripiprazole (n=194) for 6 weeks. The primary efficacy endpoint was mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score from the end of prospective treatment (baseline) to the end of randomized treatment. Results: More than 90% of patients in all treatment groups completed the 6-week double-blind treatment phase. Mean MADRS total score was improved to a significantly greater extent with fixed dose aripiprazole and flexible dose aripiprazole (-10.5 and -9.6, respectively) than with placebo ( 74). Aripiprazole was well tolerated. The incidence of akathisia observed in the flexible close group may relate to a higher prevalence of the CYP2D6*10 allele in Asian populations. Limitations: Six weeks of adjunctive treatment is insufficient to draw conclusions about the long-term benefits of aripiprazole. Exclusion of patients with established medical comorbidities does not reflect real-world practice. Conclusions: Aripiprazole augmentation at a fixed or flexible dose was superior to ADT alone and was reasonably well tolerated in Japanese patients with inadequate response to ADT. (C) 2013 The Authors. Published by Elsevier B.V. All rights reserved,

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