Efficacy and safety of aripiprazole once-monthly in Asian patients with schizophrenia: A multicenter, randomized, double-blind, non-inferiority study versus oral aripiprazole

ALPHA Study Group

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Abstract

Objective: This study was designed to evaluate efficacy and safety of aripiprazole once-monthly (AOM) by verifying non-inferiority of AOM to oral aripiprazole in Asian patients with schizophrenia. Method: The study consisted of a screening phase and three phases: an oral conversion phase (≤ 12 weeks), an oral stabilization phase (≤ 12 weeks) and a 52-week double-blind phase. Patients meeting stabilization criteria for 4. weeks during the oral stabilization phase were randomly assigned (1:1) to AOM (400. mg) or oral aripiprazole (6-24. mg/day). The primary endpoint was Kaplan-Meier estimated rate of non-exacerbation of psychotic symptoms/non-relapse at Week 26. Results: A total of 724 patients were screened, and 502 patients entered the oral stabilization phase. Of 455 patients randomized in the double-blind phase, 228 received AOM and 227 received oral aripiprazole. The non-exacerbation of psychotic symptoms/non-relapse rates at Week 26 were 95.0% (AOM) and 94.7% (oral aripiprazole) and the difference was 0.3% (95% CI: - 3.9,4.5), thus non-inferiority of AOM compared to oral aripiprazole with respect to non-exacerbation of psychotic symptoms/non-relapse rate was shown with a margin of - 3.9% which is well above the pre-defined non-inferiority limit (- 15%). The proportions of patients meeting exacerbation of psychotic symptoms/relapse criteria and stabilization of psychotic symptoms/maintenance criteria were 6.6% and 92.5% in both groups. Discontinuation rates due to all reasons were 25.9% (AOM) and 33.5% (oral aripiprazole). AOM was well tolerated as well as oral aripiprazole. Conclusions: Non-inferiority of AOM to oral aripiprazole was established. AOM is efficacious in maintenance treatment of stabilized schizophrenia, with comparable efficacy and tolerability to oral aripiprazole. Clinical Trials Registration: JapicCTI-101175.

Original languageEnglish
Pages (from-to)421-428
Number of pages8
JournalSchizophrenia Research
Volume161
Issue number2-3
DOIs
Publication statusPublished - 01-02-2015

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Schizophrenia
Safety
Aripiprazole

All Science Journal Classification (ASJC) codes

  • Psychiatry and Mental health
  • Biological Psychiatry

Cite this

@article{a88240b6ffcc4c59896d08b3d246f75b,
title = "Efficacy and safety of aripiprazole once-monthly in Asian patients with schizophrenia: A multicenter, randomized, double-blind, non-inferiority study versus oral aripiprazole",
abstract = "Objective: This study was designed to evaluate efficacy and safety of aripiprazole once-monthly (AOM) by verifying non-inferiority of AOM to oral aripiprazole in Asian patients with schizophrenia. Method: The study consisted of a screening phase and three phases: an oral conversion phase (≤ 12 weeks), an oral stabilization phase (≤ 12 weeks) and a 52-week double-blind phase. Patients meeting stabilization criteria for 4. weeks during the oral stabilization phase were randomly assigned (1:1) to AOM (400. mg) or oral aripiprazole (6-24. mg/day). The primary endpoint was Kaplan-Meier estimated rate of non-exacerbation of psychotic symptoms/non-relapse at Week 26. Results: A total of 724 patients were screened, and 502 patients entered the oral stabilization phase. Of 455 patients randomized in the double-blind phase, 228 received AOM and 227 received oral aripiprazole. The non-exacerbation of psychotic symptoms/non-relapse rates at Week 26 were 95.0{\%} (AOM) and 94.7{\%} (oral aripiprazole) and the difference was 0.3{\%} (95{\%} CI: - 3.9,4.5), thus non-inferiority of AOM compared to oral aripiprazole with respect to non-exacerbation of psychotic symptoms/non-relapse rate was shown with a margin of - 3.9{\%} which is well above the pre-defined non-inferiority limit (- 15{\%}). The proportions of patients meeting exacerbation of psychotic symptoms/relapse criteria and stabilization of psychotic symptoms/maintenance criteria were 6.6{\%} and 92.5{\%} in both groups. Discontinuation rates due to all reasons were 25.9{\%} (AOM) and 33.5{\%} (oral aripiprazole). AOM was well tolerated as well as oral aripiprazole. Conclusions: Non-inferiority of AOM to oral aripiprazole was established. AOM is efficacious in maintenance treatment of stabilized schizophrenia, with comparable efficacy and tolerability to oral aripiprazole. Clinical Trials Registration: JapicCTI-101175.",
author = "{ALPHA Study Group} and Jun Ishigooka and Jun Nakamura and Yasuo Fujii and Nakao Iwata and Toshifumi Kishimoto and Masaomi Iyo and Naohisa Uchimura and Ryoji Nishimura and Naoaki Shimizu",
year = "2015",
month = "2",
day = "1",
doi = "10.1016/j.schres.2014.12.013",
language = "English",
volume = "161",
pages = "421--428",
journal = "Schizophrenia Research",
issn = "0920-9964",
publisher = "Elsevier",
number = "2-3",

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TY - JOUR

T1 - Efficacy and safety of aripiprazole once-monthly in Asian patients with schizophrenia

T2 - A multicenter, randomized, double-blind, non-inferiority study versus oral aripiprazole

AU - ALPHA Study Group

AU - Ishigooka, Jun

AU - Nakamura, Jun

AU - Fujii, Yasuo

AU - Iwata, Nakao

AU - Kishimoto, Toshifumi

AU - Iyo, Masaomi

AU - Uchimura, Naohisa

AU - Nishimura, Ryoji

AU - Shimizu, Naoaki

PY - 2015/2/1

Y1 - 2015/2/1

N2 - Objective: This study was designed to evaluate efficacy and safety of aripiprazole once-monthly (AOM) by verifying non-inferiority of AOM to oral aripiprazole in Asian patients with schizophrenia. Method: The study consisted of a screening phase and three phases: an oral conversion phase (≤ 12 weeks), an oral stabilization phase (≤ 12 weeks) and a 52-week double-blind phase. Patients meeting stabilization criteria for 4. weeks during the oral stabilization phase were randomly assigned (1:1) to AOM (400. mg) or oral aripiprazole (6-24. mg/day). The primary endpoint was Kaplan-Meier estimated rate of non-exacerbation of psychotic symptoms/non-relapse at Week 26. Results: A total of 724 patients were screened, and 502 patients entered the oral stabilization phase. Of 455 patients randomized in the double-blind phase, 228 received AOM and 227 received oral aripiprazole. The non-exacerbation of psychotic symptoms/non-relapse rates at Week 26 were 95.0% (AOM) and 94.7% (oral aripiprazole) and the difference was 0.3% (95% CI: - 3.9,4.5), thus non-inferiority of AOM compared to oral aripiprazole with respect to non-exacerbation of psychotic symptoms/non-relapse rate was shown with a margin of - 3.9% which is well above the pre-defined non-inferiority limit (- 15%). The proportions of patients meeting exacerbation of psychotic symptoms/relapse criteria and stabilization of psychotic symptoms/maintenance criteria were 6.6% and 92.5% in both groups. Discontinuation rates due to all reasons were 25.9% (AOM) and 33.5% (oral aripiprazole). AOM was well tolerated as well as oral aripiprazole. Conclusions: Non-inferiority of AOM to oral aripiprazole was established. AOM is efficacious in maintenance treatment of stabilized schizophrenia, with comparable efficacy and tolerability to oral aripiprazole. Clinical Trials Registration: JapicCTI-101175.

AB - Objective: This study was designed to evaluate efficacy and safety of aripiprazole once-monthly (AOM) by verifying non-inferiority of AOM to oral aripiprazole in Asian patients with schizophrenia. Method: The study consisted of a screening phase and three phases: an oral conversion phase (≤ 12 weeks), an oral stabilization phase (≤ 12 weeks) and a 52-week double-blind phase. Patients meeting stabilization criteria for 4. weeks during the oral stabilization phase were randomly assigned (1:1) to AOM (400. mg) or oral aripiprazole (6-24. mg/day). The primary endpoint was Kaplan-Meier estimated rate of non-exacerbation of psychotic symptoms/non-relapse at Week 26. Results: A total of 724 patients were screened, and 502 patients entered the oral stabilization phase. Of 455 patients randomized in the double-blind phase, 228 received AOM and 227 received oral aripiprazole. The non-exacerbation of psychotic symptoms/non-relapse rates at Week 26 were 95.0% (AOM) and 94.7% (oral aripiprazole) and the difference was 0.3% (95% CI: - 3.9,4.5), thus non-inferiority of AOM compared to oral aripiprazole with respect to non-exacerbation of psychotic symptoms/non-relapse rate was shown with a margin of - 3.9% which is well above the pre-defined non-inferiority limit (- 15%). The proportions of patients meeting exacerbation of psychotic symptoms/relapse criteria and stabilization of psychotic symptoms/maintenance criteria were 6.6% and 92.5% in both groups. Discontinuation rates due to all reasons were 25.9% (AOM) and 33.5% (oral aripiprazole). AOM was well tolerated as well as oral aripiprazole. Conclusions: Non-inferiority of AOM to oral aripiprazole was established. AOM is efficacious in maintenance treatment of stabilized schizophrenia, with comparable efficacy and tolerability to oral aripiprazole. Clinical Trials Registration: JapicCTI-101175.

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