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
ARTICLE HIGHLIGHTS
Research background

Gambling disorder is one type of mental disorders that has a serious impact on patient's life, as well as their families. There have been some treatment strategies developed, but none of them are decisively effective.

Research motivation

There are many who suffer from gambling disorder. We have been engaged in their treatment in the clinical setting, but several patients fail to be respond to treatment due to several reasons. We strongly want to develop treatment options for non-responders.

Research objectives

The aim of the research was to examine the effectiveness and safety of blonanserin, a novel dopamine D3 antagonist, on gambling disorder.

Research methods

We developed a study protocol in which participants take blonanserin up to 12 mg/d for 8 wk. We evaluated its effect and safety with several rating scales.

Research results

One patient participated in this clinical trial. She had improved clinical symptoms of gambling disorder, but due to an adverse effect, quit taking blonanserin.

Research conclusions

This case suggests the potential effect of blonanserin to mitigate the symptoms of gambling disorder. On the other hand, extrapyramidal side effect should be cautiously addressed.

Research perspectives

We believe the study protocol presented is applicable to a randomized controlled trial with larger sample size.