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Authors
Kato, Masaki
Shiosakai, Masako
Kuwahara, Kazuo
Iba, Katsuhiro
Shimada, Yuki
Saito, Mizuki
Sekine, Daisuke
Aoki, Kazuo https://orcid.org/0009-0002-6635-4218
Shiomi, Yuki
Higuchi, Teruhiko
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Clinical Trials BETA
Clinical trials referenced in this document:
nct03737474 at ClinicalTrials.govDocuments that mention this clinical trial
A Multicenter, Open-Label Study to Evaluate the Long-term Safety and Efficacy of Adjunctive Brexpiprazole 2 mg Daily in Japanese Patients with Major Depressive Disorder
https://doi.org/10.1007/s40263-024-01124-w
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Funding
Funding for this research was provided by:
Otsuka Pharmaceutical Co., Ltd.
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Article History
Accepted: 4 September 2024
First Online: 18 October 2024
Declarations
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: This study was funded by Otsuka Pharmaceutical Co., Ltd. The sponsor participated in the design and conduction of the study and in the collection, management, analysis, and interpretation of the data and funded the preparation of the manuscript. All authors, including those affiliated with the sponsor, fulfilled all authorship criteria and participated in the review and approval of the manuscript and in the decision to submit the manuscript for publication. Medical writing support was provided by Jordana Campbell, BSc, CMPP, of inScience Communications, Springer Healthcare. This medical writing assistance and the open access fee were funded by Otsuka Pharmaceutical Co., Ltd.
: M.K. reports consulting fees for this study from Otsuka Pharmaceutical Co., Ltd.; consulting fees from outside of this study from Sumitomo Pharma Co., Ltd., Shionogi & Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Lundbeck Japan K.K., and Takeda Pharmaceutical Co., Ltd.; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Sumitomo Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Meiji Seika Pharma Co., Ltd., Eli Lilly Japan K.K., MSD K.K., Pfizer Japan Inc., Janssen Pharmaceutical K.K., Shionogi & Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Ltd., Lundbeck Japan K.K., Viatris Inc., Eisai Co., Ltd., Kyowa Pharmaceutical Industry Co., Ltd., and Ono Pharmaceutical Co., Ltd. M.S., K.K., K.I., Y.S., M.S., D.S., K.A., and Y.S. are full-time employees of Otsuka Pharmaceutical Co., Ltd. T.H. reports consulting fees for this study and honoraria for lectures from Otsuka Pharmaceutical Co., Ltd.
: Anonymized individual participant data that underlie the results of this study will be shared with researchers to achieve aims prespecified in a methodologically sound research proposal.
: Not applicable.
: The study protocol, protocol amendment(s), and all study-related documents were reviewed and approved by the local or central institutional review board (IRB) at each participating institution. The study was conducted in accordance with the protocol, and complied with Good Clinical Practice (GCP) guidelines, Declaration of Helsinki, and all local laws.
: All patients provided written informed consent to participate in the study.
: Not applicable.
: Study concept and design: M. Kato, M. Shiosakai, K. Kuwahara, K. Iba, Y. Shimada, M. Saito, and T. Higuchi. Acquisition of data: M. Kato, M. Shiosakai, K. Kuwahara, K. Iba, Y. Shimada, M. Saito, and T. Higuchi. Analysis and interpretation of data, drafting of the manuscript, revision of it for intellectual content, and final approval of the completed manuscript: All authors. Read and approved the final submitted manuscript and agree to be accountable for the work: All authors.
