Randomized Controlled Trial
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Psychiatry. Aug 19, 2025; 15(8): 104221
Published online Aug 19, 2025. doi: 10.5498/wjp.v15.i8.104221
Application and efficacy of quetiapine in patients with high-risk factors for bipolar disorder: A randomized controlled trial
Li-Lei Lei, Chen-Jie Ge, Hong Wang, Yu Fang, Lei Zeng, Shi-Liang Wang, Min-Cai Qian
Li-Lei Lei, Lei Zeng, Min-Cai Qian, Department of Neurosis and Psychosomatic Diseases, Huzhou Third Municipal Hospital, The Affiliated Hospital of Huzhou University, Huzhou 313000, Zhejiang Province, China
Chen-Jie Ge, Shi-Liang Wang, Quality Management Division, Huzhou Third Municipal Hospital, The Affiliated Hospital of Huzhou University, Huzhou 313000, Zhejiang Province, China
Hong Wang, Yu Fang, Department of Geriatric Psychiatry, Huzhou Third Municipal Hospital, The Affiliated Hospital of Huzhou University, Huzhou 313000, Zhejiang Province, China
Author contributions: Lei LL made significant contributions to formal analysis, specific experimental process management, data curation, and writing-original draft; Ge CJ made significant contributions to research design and data analysis; Wang H made significant contributions to experimental technical support and results section; Fang Y contributed to supervision, validation and writing-review & editing; Zeng L and Wang SL contributed to investigation, methodology and writing-review & editing; Qian MC contributed to funding acquisition, resources and writing-review & editing. All authors reviewed the manuscript.
Supported by Huzhou City Science and Technology Plan Public Welfare Technology Application Research Project [Key Project], No. 2020GZ42.
Institutional review board statement: All experimental protocols were approved by the Ethics Committee of Huzhou Third Municipal Hospital. All participants volunteered for this study and signed written informed consent. All methods were carried out in accordance with Declaration of Helsinki.
Clinical trial registration statement: The registration process for this study is currently underway. While the registration number is pending due to administrative review timelines, we confirm compliance with ethical standards and transparency requirements. The registration number will be included in the final manuscript prior to acceptance.
Informed consent statement: All participants volunteered for this study and signed written informed consent.
Conflict-of-interest statement: The authors declare that there are no conflicts of interest regarding the publication of this paper.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: The data used to support the findings of this study are available from the corresponding author on reasonable request.
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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Min-Cai Qian, Department of Neurosis and Psychosomatic Diseases, Huzhou Third Municipal Hospital, The Affiliated Hospital of Huzhou University, No. 2088 East Campsis Road, Huzhou 313000, Zhejiang Province, China. 13757289002@163.com
Received: December 19, 2024
Revised: April 11, 2025
Accepted: June 16, 2025
Published online: August 19, 2025
Processing time: 238 Days and 4.2 Hours
Abstract
BACKGROUND

Bipolar disorder (BD), marked by recurring manic and depressive episodes, often coexists with anxiety disorder (AD), which increases treatment complexity and morbidity. Although quetiapine, an atypical antipsychotic, has demonstrated efficacy in treating BD and AD, further investigation is needed regarding its effectiveness and safety in patients with AD at high-risk factors for BD.

AIM

To explore the application and efficacy of quetiapine in combination therapy for patients with AD at high-risk factors for BD.

METHODS

This study included 67 patients, with two excluded, leaving 65 divided into Group A (sertraline treatment) and Group B (combination treatment). All patients received sertraline, with Group B additionally receiving quetiapine. Efficacy was assessed using the Hamilton anxiety scale (HAMA), Hamilton depression scale (HAMD), and Bech-Rafaelsen Mania sale (BRMS) throughout the treatment period. Side effects and physiological indicators were also monitored.

RESULTS

No significant baseline differences existed between the two groups at treatment onset. Over the treatment course, Group B exhibited significantly lower HAMA scores than Group A at the end of weeks 1 and 24. HAMD scores gradually decreased over time, with Group B consistently showing lower scores than Group A. BRMS scores decreased significantly from baseline by week 8. In Group A, 27.27% of patients received zolpidem treatment compared to 10.53% in Group B, which was a significant difference. Incidence of adverse reactions did not differ significantly between groups at treatment onset, but most patients experienced relief from adverse reactions within 4 weeks.

CONCLUSION

Combination of quetiapine and sertraline can more rapidly alleviate anxiety and depressive symptoms in patients with AD at high-risk factors for BD, improving treatment outcomes.

Keywords: Bipolar disorder; Anxiety disorders; Quetiapine; Comorbidity; Risk factor

Core Tip: This study evaluated the efficacy and safety of quetiapine combined with sertraline in patients with anxiety disorder (AD) and high-risk factors for bipolar disorder (BD). In a 24-week randomized trial involving 65 patients, those receiving combination therapy (Group B) showed significantly lower Hamilton anxiety scale scores than those on sertraline monotherapy (Group A) at weeks 1 and 24. Group B also demonstrated faster and sustained reductions in Hamilton depression scale and Bech-Rafaelsen Mania sale scores. Group B required less adjunctive zolpidem for insomnia, with no significant difference in adverse reactions between the groups. These findings support the use of quetiapine as an adjunctive treatment for managing complex AD at high-risk factors for BD, offering a safer and more effective strategy for high-risk patients.