Clinical Trials Registration: ClinicalTrials.gov identifier NCT00876343.
Efficacy of aripiprazole augmentation in Japanese patients with major depressive disorder: A subgroup analysis and Montgomery–Åsberg Depression Rating Scale and Hamilton Rating Scale for Depression item analyses of the Aripiprazole Depression Multicenter Efficacy study
Version of Record online: 4 AUG 2014
© 2014 The Authors. Psychiatry and Clinical Neurosciences © 2014 Japanese Society of Psychiatry and Neurology
Psychiatry and Clinical Neurosciences
Special Issue: Conquering depression
Volume 69, Issue 1, pages 34–42, January 2015
How to Cite
Ozaki, N., Otsubo, T., Kato, M., Higuchi, T., Ono, H., Kamijima, K. and ADMIRE Study Group (2015), Efficacy of aripiprazole augmentation in Japanese patients with major depressive disorder: A subgroup analysis and Montgomery–Åsberg Depression Rating Scale and Hamilton Rating Scale for Depression item analyses of the Aripiprazole Depression Multicenter Efficacy study. Psychiatry and Clinical Neurosciences, 69: 34–42. doi: 10.1111/pcn.12214
- Issue online: 4 JAN 2015
- Version of Record online: 4 AUG 2014
- Accepted manuscript online: 26 JUN 2014 05:59AM EST
- Manuscript Accepted: 21 JUN 2014
- Manuscript Revised: 12 JUN 2014
- Manuscript Received: 15 MAY 2014
- Otsuka Pharmaceutical Co., Ltd
- augmentation therapy;
- major depressive disorder;
- subgroup analysis
Results from this randomized, placebo-controlled study of aripiprazole augmentation to antidepressant therapy (ADT) in Japanese patients with major depressive disorder (MDD) (the Aripiprazole Depression Multicenter Efficacy [ADMIRE] study) revealed that aripiprazole augmentation was superior to ADT alone and was well tolerated. In subgroup analyses, we investigated the influence of demographic- and disease-related factors on the observed responses. We also examined how individual symptom improvement was related to overall improvement in MDD.
Data from the ADMIRE study were analyzed. Subgroup analyses were performed on the primary outcome measures: the mean change in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score from the end of selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) treatment to the end of the randomized treatment.
Changes in the MADRS total scores were consistently greater with aripiprazole than placebo in each of the subgroups. Efficacy was not related to sex, age, number of adequate ADT trials in the current episode, MDD diagnosis, number of depressive episodes, duration of the current episode, age at first depressive episode, time since the first depressive episode, type of SSRI/SNRI, or severity at the end of SSRI/SNRI treatment phase. Compared to placebo, aripiprazole resulted in significant and rapid improvement on seven of the 10 MADRS items, including sadness.
These post-hoc analyses indicated that aripiprazole was effective for a variety of Japanese patients with MDD who had exhibited inadequate responses to ADT. Additionally, we suggest that aripiprazole significantly and rapidly improved the core depressive symptoms.