Defining Treatment-Resistant Bipolar Depression: Recommendations From the ISBD Task Force

IF 4.5 2区医学 Q1 CLINICAL NEUROLOGY

Bipolar Disorders Pub Date : 2025-08-13 DOI:10.1111/bdi.70048

Eduard Vieta, Roger S. McIntyre, Trisha Suppes, Tamsyn E. Van Rheenen, Balwinder Singh, Kamilla Woznica Miskowiak, Allan H. Young, Lakshmi N. Yatham, Kyooseob Ha, Michael Berk, Holly A. Swartz, Chantal Henry, Maja Pantovic Stefanovic, Gerard Anmella Diaz, Aysegul Ozerdem, Wiesław J. Cubała, Diego Hidalgo-Mazzei, Mauricio Tohen, Isabella Pacchiarotti, Paula Villela Nunes, Carlos Lopez-Jaramillo, Ana Gonzalez-Pinto, Paolo Brambilla, Robert Post, Jair C. Soares, Michael Bauer, Ana C. Andreazza, Xavier Justes Fradera, Montserrat Cosials-Lopez, Giovanna Fico

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引用次数: 0

Abstract

Objective

Despite the availability of approved treatments, a substantial proportion of patients with bipolar disorder experience treatment-resistant bipolar depression (TRBD), characterized by persistent depressive symptoms unresponsive to standard therapies. However, a universally accepted definition of TRBD is lacking. This consensus document, developed by the International Society for Bipolar Disorders (ISBD) Task Force on TRBD, aims to provide a standardized definition of TRBD to facilitate clinical trials, research, and treatment strategies.

Methods

The Task Force employed a literature review, clinical trials analysis, and expert consensus meetings to define TRBD.

Results

TRBD was defined as the failure to achieve a significant and sustained clinical response after at least two approved and adequately dosed pharmacological treatments, administered for a sufficient duration with treatment adherence. For bipolar I (BD-I) depression, approved treatments included quetiapine (300–600 mg/day for ≥ 8 weeks), lurasidone (20–120 mg/day for ≥ 6 weeks), the combination of olanzapine (6–12 mg/day) and fluoxetine (25–75 mg/day for ≥ 8 weeks), cariprazine (1.5–3 mg/day for ≥ 6 weeks), and lumateperone (42 mg/day for ≥ 6 weeks). For bipolar II (BD-II) depression, approved treatments included quetiapine (300–600 mg/day for ≥ 8 weeks) and lumateperone (42 mg/day for ≥ 6 weeks).

Conclusion

This consensus definition aims to provide clarity for clinical trials, improve consistency in research, and guide treatment approaches and inform regulatory pathways. It represents a foundational step in addressing the unmet needs in TRBD and promoting the development of innovative therapeutic strategies. Future efforts will focus on adapting the definition to better align with real-world clinical challenges and optimize patient care.

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定义难治性双相抑郁症：来自ISBD工作组的建议。

目的：尽管有批准的治疗方法，但相当比例的双相情感障碍患者经历治疗抵抗性双相情感障碍（TRBD），其特征是持续的抑郁症状对标准治疗无反应。然而，缺乏一个普遍接受的TRBD定义。这份共识文件由国际双相情感障碍学会（ISBD） TRBD工作组制定，旨在提供TRBD的标准化定义，以促进临床试验、研究和治疗策略。方法：工作组采用文献综述、临床试验分析和专家共识会议来定义TRBD。结果：TRBD被定义为在至少两种经批准且剂量充足的药物治疗后，在坚持治疗的情况下给予足够的持续时间，未能达到显著和持续的临床反应。对于双相I型（dd -I）抑郁症，批准的治疗包括喹硫平（300- 600mg /天，持续≥8周）、鲁拉西酮（20- 120mg /天，持续≥6周）、奥氮平（6- 12mg /天）和氟西汀（25- 75mg /天，持续≥8周）、卡吡嗪（1.5- 3mg /天，持续≥6周）和lumateperone （42 mg/天，持续≥6周）。对于双相II型（BD-II）抑郁症，批准的治疗包括喹硫平（300- 600mg /天，持续≥8周）和lumateperone （42 mg/天，持续≥6周）。结论：该共识定义旨在为临床试验提供清晰度，提高研究一致性，指导治疗方法和告知监管途径。它代表了解决TRBD未满足需求和促进创新治疗策略发展的基础步骤。未来的努力将集中于调整定义，以更好地与现实世界的临床挑战相一致，并优化患者护理。

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来源期刊

Bipolar Disorders 医学-精神病学

CiteScore

8.20

自引率

7.40%

发文量

审稿时长

6-12 weeks

期刊介绍： Bipolar Disorders is an international journal that publishes all research of relevance for the basic mechanisms, clinical aspects, or treatment of bipolar disorders and related illnesses. It intends to provide a single international outlet for new research in this area and covers research in the following areas: biochemistry physiology neuropsychopharmacology neuroanatomy neuropathology genetics brain imaging epidemiology phenomenology clinical aspects and therapeutics of bipolar disorders Bipolar Disorders also contains papers that form the development of new therapeutic strategies for these disorders as well as papers on the topics of schizoaffective disorders, and depressive disorders as these can be cyclic disorders with areas of overlap with bipolar disorders. The journal will consider for publication submissions within the domain of: Perspectives, Research Articles, Correspondence, Clinical Corner, and Reflections. Within these there are a number of types of articles: invited editorials, debates, review articles, original articles, commentaries, letters to the editors, clinical conundrums, clinical curiosities, clinical care, and musings.