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

Kunitoshi Kamijima, Teruhiko Higuchi, Jun Ishigooka, Tetsuro Ohmori, Norio Ozaki, Shigenobu Kanba, Toshihiko Kinoshita, Tsukasa Koyama

研究成果: ジャーナルへの寄稿記事

27 引用 (Scopus)

抄録

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-Åsberg 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 (-7.4). Aripiprazole was well tolerated. The incidence of akathisia observed in the flexible dose 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. Clinical trials registration ClinicalTrials.gov identifier NCT00876343.

元の言語英語
ページ(範囲)899-905
ページ数7
ジャーナルJournal of Affective Disorders
151
発行部数3
DOI
出版物ステータス出版済み - 12 1 2013

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Major Depressive Disorder
Antidepressive Agents
Placebos
Therapeutics
Aripiprazole
Psychomotor Agitation
Cytochrome P-450 CYP2D6
Comorbidity
Appointments and Schedules
Alleles
Clinical Trials

All Science Journal Classification (ASJC) codes

  • Clinical Psychology
  • Psychiatry and Mental health

これを引用

Aripiprazole augmentation to antidepressant therapy in Japanese patients with major depressive disorder : A randomized, double-blind, placebo-controlled study (ADMIRE study). / Kamijima, Kunitoshi; Higuchi, Teruhiko; Ishigooka, Jun; Ohmori, Tetsuro; Ozaki, Norio; Kanba, Shigenobu; Kinoshita, Toshihiko; Koyama, Tsukasa.

:: Journal of Affective Disorders, 巻 151, 番号 3, 01.12.2013, p. 899-905.

研究成果: ジャーナルへの寄稿記事

Kamijima, Kunitoshi ; Higuchi, Teruhiko ; Ishigooka, Jun ; Ohmori, Tetsuro ; Ozaki, Norio ; Kanba, Shigenobu ; Kinoshita, Toshihiko ; Koyama, Tsukasa. / 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. 2013 ; 巻 151, 番号 3. pp. 899-905.
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abstract = "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-{\AA}sberg 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 (-7.4). Aripiprazole was well tolerated. The incidence of akathisia observed in the flexible dose 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. Clinical trials registration ClinicalTrials.gov identifier NCT00876343.",
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T2 - A randomized, double-blind, placebo-controlled study (ADMIRE study)

AU - Kamijima, Kunitoshi

AU - Higuchi, Teruhiko

AU - Ishigooka, Jun

AU - Ohmori, Tetsuro

AU - Ozaki, Norio

AU - Kanba, Shigenobu

AU - Kinoshita, Toshihiko

AU - Koyama, Tsukasa

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N2 - 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-Åsberg 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 (-7.4). Aripiprazole was well tolerated. The incidence of akathisia observed in the flexible dose 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. Clinical trials registration ClinicalTrials.gov identifier NCT00876343.

AB - 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-Åsberg 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 (-7.4). Aripiprazole was well tolerated. The incidence of akathisia observed in the flexible dose 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. Clinical trials registration ClinicalTrials.gov identifier NCT00876343.

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