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

Research output: Contribution to journalArticle

27 Citations (Scopus)

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-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.

Original languageEnglish
Pages (from-to)899-905
Number of pages7
JournalJournal of Affective Disorders
Volume151
Issue number3
DOIs
Publication statusPublished - Dec 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

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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.

In: Journal of Affective Disorders, Vol. 151, No. 3, 01.12.2013, p. 899-905.

Research output: Contribution to journalArticle

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). In: Journal of Affective Disorders. 2013 ; Vol. 151, No. 3. pp. 899-905.
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AU - Ohmori, Tetsuro

AU - Ozaki, Norio

AU - Kanba, Shigenobu

AU - Kinoshita, Toshihiko

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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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