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Divergence of dose–response with asenapine: a cluster analysis of randomized, double-blind, and placebo control study

Published online by Cambridge University Press:  19 January 2021

Yoshiteru Takekita*
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
Shuichi Hiraoka
Affiliation:
Medical Science Section, Pharmaceutical Research & Development Division, Meiji Seika Pharma Co., Ltd., Tokyo, Japan
Yasuhiro Iwama
Affiliation:
Regulatory & Datascience Department, Pharmaceutical Research & Development Division, Meiji Seika Pharma Co., Ltd., Tokyo, Japan
Naotaka Sunada
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
Nobuatsu Aoki
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
Haruhiko Ogata
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
Toshiya Funatsuki
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
Chikashi Takano
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
Tomoyo Yanagida
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
Yosuke Koshikawa
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
Minami Naito
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
Atsuko Yamamoto
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
Masaki Kato
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
Toshihiko Kinoshita
Affiliation:
Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan
*
*Author for correspondence: Yoshiteru Takekita Email: takekity@takii.kmu.ac.jp

Abstract

Background

Differences in psychiatric background and dose–response to asenapine in patients with schizophrenia were examined based on efficacy and safety, using data obtained in a double-blind, placebo-controlled trial.

Methods

Patients with schizophrenia were classified into three clusters by a cluster analysis based on the Positive and Negative Symptom Scale (PANSS) subscores at baseline, using the data from a 6-week, double-blind, placebo-controlled trial. PANSS Marder factor scores were calculated for each cluster. The efficacy of 10 or 20 mg/day of asenapine on PANSS score was used as the primary endpoint, with the incidence of adverse events evaluated as the secondary endpoint.

Results

A total of 529 asenapine-treated patients were classified into 3 clusters: Cluster-P with the higher scores in positive symptoms, disorganized thoughts, and hostility/excitement, Cluster-N with higher scores in negative symptoms, and Cluster-L with overall lower scores. In Cluster-N and Cluster-L, both 10 and 20 mg/day groups showed significant improvement in PANSS scores, while only the 20 mg/day group showed a significant difference in Cluster-P. Cluster-N and Cluster-L had differences in the incidence of adverse events, but this was not seen in Cluster-P.

Conclusions

The efficacy and safety of asenapine 10 and 20 mg/day differed between the 3 clusters of patients. This suggests that background information regarding baseline psychiatric symptoms may affect the therapeutic response in patients with schizophrenia.

Type
Original Research
Copyright
© The Author(s), 2021. Published by Cambridge University Press

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