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
Abstract
BACKGROUND

Gambling disorder is characterized by excessive and recurrent gambling and can have serious negative social consequences. Although several psychotherapeutic and pharmacological approaches have been used to treat gambling disorder, new treatment strategies are needed. Growing evidence suggests that dopamine D3 receptor plays a specific role in the brain reward system.

AIM

To investigate if blonanserin, a dopamine D3 receptor antagonist, would be effective in reducing gambling impulses in patients with gambling disorder.

METHODS

We developed a study protocol to measure the efficacy and safety of blonanserin as a potential drug for gambling disorder, in which up to 12 mg/d of blonanserin was prescribed for 8 wk.

RESULTS

A 37-year-old female patient with gambling disorder, intellectual disability, and other physical diseases participated in the pilot study. The case showed improvement of gambling symptoms without any psychotherapy. However, blonanserin was discontinued owing to excessive saliva production.

CONCLUSION

This case suggests that blonanserin is potentially an effective treatment for patients with gambling disorder who resist standard therapies, but it also carries a risk of adverse effects. Further studies are needed to confirm the findings.

Keywords: Blonanserin; Gambling disorder; Medication; Clinical trial protocol; D3 receptor; Case report

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.