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)

Shigenobu Kanba, Hiroaki Kawasaki, Jun Ishigooka, Kaoru Sakamoto, Toshihiko Kinoshita, Toshihide Kuroki

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Objectives. To investigate the efficacy and safety of aripiprazole in Asian patients with manic or mixed episodes associated with bipolar I disorder. Methods. Subjects were randomised to aripiprazole (24 mg/day; reduced to 12 mg/day if needed for tolerability; n = 128) or placebo (n = 130) for 3 weeks in this multicentre, double-blind study. The primary efficacy measure was mean change from baseline in Young Mania Rating Scale (YMRS) Total score. Results. A total of 136 patients (aripiprazole 56.3%; placebo 49.2%) completed the study. The majority of patients (92.6%) received aripiprazole 24 mg/day. Aripiprazole produced statistically significant mean improvements in YMRS Total scores compared with placebo from Day 4 through to Week 3 (-11.3 vs.-5.3; P < 0.001). The most common adverse events (> 15% of patients; aripiprazole vs. placebo) were akathisia (22.0 vs. 5.6%) and insomnia (16.3 vs. 9.6%). Aripiprazole treatment resulted in no significant difference from placebo in change in mean body weight from baseline (-0.4 vs.-0.7 kg; P = 0.231). Aripiprazole was not associated with an elevated serum prolactin level. Conclusions. Aripiprazole had significantly greater efficacy than placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder in Asian patients. Treatment was generally safe and well tolerated.

Original languageEnglish
Pages (from-to)113-121
Number of pages9
JournalWorld Journal of Biological Psychiatry
Volume15
Issue number2
DOIs
Publication statusPublished - Feb 1 2014

Fingerprint

Bipolar Disorder
Double-Blind Method
Placebos
Safety
Therapeutics
Aripiprazole
Psychomotor Agitation
Sleep Initiation and Maintenance Disorders
Prolactin
Body Weight
Serum

All Science Journal Classification (ASJC) codes

  • Psychiatry and Mental health
  • Biological Psychiatry

Cite this

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). / Kanba, Shigenobu; Kawasaki, Hiroaki; Ishigooka, Jun; Sakamoto, Kaoru; Kinoshita, Toshihiko; Kuroki, Toshihide.

In: World Journal of Biological Psychiatry, Vol. 15, No. 2, 01.02.2014, p. 113-121.

Research output: Contribution to journalArticle

@article{a7ac75556edc425386ab586a5c5418f1,
title = "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)",
abstract = "Objectives. To investigate the efficacy and safety of aripiprazole in Asian patients with manic or mixed episodes associated with bipolar I disorder. Methods. Subjects were randomised to aripiprazole (24 mg/day; reduced to 12 mg/day if needed for tolerability; n = 128) or placebo (n = 130) for 3 weeks in this multicentre, double-blind study. The primary efficacy measure was mean change from baseline in Young Mania Rating Scale (YMRS) Total score. Results. A total of 136 patients (aripiprazole 56.3{\%}; placebo 49.2{\%}) completed the study. The majority of patients (92.6{\%}) received aripiprazole 24 mg/day. Aripiprazole produced statistically significant mean improvements in YMRS Total scores compared with placebo from Day 4 through to Week 3 (-11.3 vs.-5.3; P < 0.001). The most common adverse events (> 15{\%} of patients; aripiprazole vs. placebo) were akathisia (22.0 vs. 5.6{\%}) and insomnia (16.3 vs. 9.6{\%}). Aripiprazole treatment resulted in no significant difference from placebo in change in mean body weight from baseline (-0.4 vs.-0.7 kg; P = 0.231). Aripiprazole was not associated with an elevated serum prolactin level. Conclusions. Aripiprazole had significantly greater efficacy than placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder in Asian patients. Treatment was generally safe and well tolerated.",
author = "Shigenobu Kanba and Hiroaki Kawasaki and Jun Ishigooka and Kaoru Sakamoto and Toshihiko Kinoshita and Toshihide Kuroki",
year = "2014",
month = "2",
day = "1",
doi = "10.3109/15622975.2012.669047",
language = "English",
volume = "15",
pages = "113--121",
journal = "World Journal of Biological Psychiatry",
issn = "1562-2975",
publisher = "Informa Healthcare",
number = "2",

}

TY - JOUR

T1 - 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)

AU - Kanba, Shigenobu

AU - Kawasaki, Hiroaki

AU - Ishigooka, Jun

AU - Sakamoto, Kaoru

AU - Kinoshita, Toshihiko

AU - Kuroki, Toshihide

PY - 2014/2/1

Y1 - 2014/2/1

N2 - Objectives. To investigate the efficacy and safety of aripiprazole in Asian patients with manic or mixed episodes associated with bipolar I disorder. Methods. Subjects were randomised to aripiprazole (24 mg/day; reduced to 12 mg/day if needed for tolerability; n = 128) or placebo (n = 130) for 3 weeks in this multicentre, double-blind study. The primary efficacy measure was mean change from baseline in Young Mania Rating Scale (YMRS) Total score. Results. A total of 136 patients (aripiprazole 56.3%; placebo 49.2%) completed the study. The majority of patients (92.6%) received aripiprazole 24 mg/day. Aripiprazole produced statistically significant mean improvements in YMRS Total scores compared with placebo from Day 4 through to Week 3 (-11.3 vs.-5.3; P < 0.001). The most common adverse events (> 15% of patients; aripiprazole vs. placebo) were akathisia (22.0 vs. 5.6%) and insomnia (16.3 vs. 9.6%). Aripiprazole treatment resulted in no significant difference from placebo in change in mean body weight from baseline (-0.4 vs.-0.7 kg; P = 0.231). Aripiprazole was not associated with an elevated serum prolactin level. Conclusions. Aripiprazole had significantly greater efficacy than placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder in Asian patients. Treatment was generally safe and well tolerated.

AB - Objectives. To investigate the efficacy and safety of aripiprazole in Asian patients with manic or mixed episodes associated with bipolar I disorder. Methods. Subjects were randomised to aripiprazole (24 mg/day; reduced to 12 mg/day if needed for tolerability; n = 128) or placebo (n = 130) for 3 weeks in this multicentre, double-blind study. The primary efficacy measure was mean change from baseline in Young Mania Rating Scale (YMRS) Total score. Results. A total of 136 patients (aripiprazole 56.3%; placebo 49.2%) completed the study. The majority of patients (92.6%) received aripiprazole 24 mg/day. Aripiprazole produced statistically significant mean improvements in YMRS Total scores compared with placebo from Day 4 through to Week 3 (-11.3 vs.-5.3; P < 0.001). The most common adverse events (> 15% of patients; aripiprazole vs. placebo) were akathisia (22.0 vs. 5.6%) and insomnia (16.3 vs. 9.6%). Aripiprazole treatment resulted in no significant difference from placebo in change in mean body weight from baseline (-0.4 vs.-0.7 kg; P = 0.231). Aripiprazole was not associated with an elevated serum prolactin level. Conclusions. Aripiprazole had significantly greater efficacy than placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder in Asian patients. Treatment was generally safe and well tolerated.

UR - http://www.scopus.com/inward/record.url?scp=84893854296&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84893854296&partnerID=8YFLogxK

U2 - 10.3109/15622975.2012.669047

DO - 10.3109/15622975.2012.669047

M3 - Article

C2 - 22540407

AN - SCOPUS:84893854296

VL - 15

SP - 113

EP - 121

JO - World Journal of Biological Psychiatry

JF - World Journal of Biological Psychiatry

SN - 1562-2975

IS - 2

ER -