Clinical Trials Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Apr 16, 2021; 9(11): 2469-2477
Published online Apr 16, 2021. doi: 10.12998/wjcc.v9.i11.2469
Possible effect of blonanserin on gambling disorder: A clinical study protocol and a case report
Akihiro Shiina, Tadashi Hasegawa, Masaomi Iyo
Akihiro Shiina, Division of Medical Treatment and Rehabilitation, Chiba University Center for Forensic Mental Health, Chiba 260-8670, Japan
Tadashi Hasegawa, Department of Psychiatry, Chiba University Hospital, Chiba 260-8670, Japan
Masaomi Iyo, Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba 260-8670, Japan
Author contributions: Shiina A acquired the study grant and developed the study protocol; Hasegawa T contributed to participant recruitment; Shiina A and Hasegawa T evaluated participant status; Shiina A wrote the manuscript; Iyo M was the administrator of the project; All authors approved the manuscript.
Supported by The Grant from Council for Addiction Behavior Studies.
Institutional review board statement: The study protocol was approved by the Institutional Review Board of Chiba University Hospital, which approved the implementation of this study as a clinical trial on January 7, 2016 (G27039, No. 65).
Clinical trial registration statement: We registered this study protocol with the UMIN Clinical Trial Registry on Jan 20, 2016 (R000023855, UMIN000020669).
Informed consent statement: The researcher obtained written informed consent from every participant prior to the beginning of the trial.
Conflict-of-interest statement: This study was supported by a grant from the Council for Addiction Behavior Studies, a non-profit organization in Japan. The last author received research funds and a lecture fee from Dainippon Sumitomo Pharma. We have no other conflicts of interest to declare.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: This study completely adhered to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Akihiro Shiina, MD, MSc, PhD, Associate Professor, Division of Medical Treatment and Rehabilitation, Chiba University Center for Forensic Mental Health, Inohana 1-8-1, Chuoh-ku, Chiba 260-8670, Japan. shiina-akihiro@faculty.chiba-u.jp
Received: December 14, 2020
Peer-review started: December 14, 2020
First decision: December 31, 2020
Revised: January 8, 2021
Accepted: February 1, 2021
Article in press: February 1, 2021
Published online: April 16, 2021
Processing time: 109 Days and 10.7 Hours
Core Tip

Core Tip: We developed a study protocol to examine the effect and safety of blonanserin on gambling disorder. A case was introduced in the study, to bring a promising outcome, but treatment was discontinued due to extrapyramidal adverse effects. A safer usage should be established.