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Efficacy and safety of fixed doses of intranasal Esketamine as an add-on therapy to Oral antidepressants in Japanese patients with treatment-resistant depression: a phase 2b randomized clinical study

Crossref DOI link: https://doi.org/10.1186/s12888-021-03538-y

Published Online: 2021-10-25

Published Print: 2021-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Takahashi, Nagahide

Yamada, Aya

Shiraishi, Ayako

Shimizu, Hiroko

Goto, Ryosuke

Tominaga, Yushin
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Text and Data Mining valid from 2021-10-25

Version of Record valid from 2021-10-25
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Article History

Received: 12 February 2021

Accepted: 7 October 2021

First Online: 25 October 2021

Declarations

:

: The study protocol and all amendments were approved by the institutional review board (IRB) at each study site (representative of IRB: National Center Hospital, National Center of Neurology and Psychiatry; Reference number: S-261). The study was conducted in compliance with the ethical principles of the Declaration of Helsinki, International Council for Harmonisation (ICH) Good Clinical Practice (GCP), and applicable regulatory requirements. Informed consent was obtained from all the participants.

: Not applicable.

: The authors report conflicts of interest in this work. AY, AS, HS, RG, and YT are full time employees of Janssen Pharmaceutical K.K., Tokyo, Japan. NT is a contract Study Responsible Physician of Janssen Pharmaceutical K.K., Tokyo, Japan.

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