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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 Open the ORCID record for Yoshiteru Takekita [Opens in a new window] ,
Shuichi Hiraoka ,
Yasuhiro Iwama ,
Naotaka Sunada ,
Nobuatsu Aoki ,
Haruhiko Ogata ,
Toshiya Funatsuki ,
Chikashi Takano ,
Tomoyo Yanagida  and
Yosuke Koshikawa
...Show all authors
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
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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.

Keywords

Antipsychoticasenapinecluster analysisdose responseschizophrenia
Type
Original Research
Information
CNS Spectrums , Volume 27 , Issue 3 , June 2022 , pp. 369 - 377
Copyright
© The Author(s), 2021. Published by Cambridge University Press

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