双相情感障碍：已批准的精神药物（2008-2024）和正在进行的第三期药物的系统回顾。

IF 4.9 2区医学 Q1 CLINICAL NEUROLOGY

Journal of affective disorders Pub Date : 2025-06-27 DOI:10.1016/j.jad.2025.119778

Salma Ramadan , Laurel Tay , Harlene Kaur , Thomas Parrish , Salma Abdelmoteleb , Jayant Totlani , Emile Tadros , Drew Hirsch , Nathalie Murphy , Ashley Meyer , Macie Miller , Mia Pasini , Aasim Naqvi , Angela Liu , Romana Dymkoski , Sabrina Renteria , Rebecca Hedrick , Itai Danovitch , Robert Pechnick , Waguih William IsHak

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引用次数: 0

摘要

目的：本系统综述评估了2008年至2024年间美国FDA批准的治疗双相情感障碍（BP）的精神药物，以及处于高级临床开发阶段的研究药物，以及具有探索性证据的药物。它根据临床相关性、作用机制、疗效、剂量、不良反应、指南和实际使用对这些治疗进行了分类。方法：系统检索PubMed、FDALabel和ClinicalTrials.gov数据库中2008年至2024年间发表的研究，检索关键词包括“bipolar”和“psychopharm*”或“medic*”或“pharm*”。两名审稿人独立评估了最终的出版物，通过共识解决任何差异，最终确定纳入本综述的研究。从选定的全文文章中提取关键发现，以编制审查表的数据。我们还使用了美国、加拿大、英国和澳大利亚/新西兰的BP实践指南。结果：降压药物被分为三层：(1)fda批准和指南认可，(2)fda批准，临床应用前景良好，(3)iii期药物。我们描述了从2008年到2024年获得FDA批准的8种一级和8种二级药物，7种正在进行iii期临床试验，还有6种具有探索性证据的药物。结论：在过去的16 年中，双相情感障碍的药物治疗进展反映了向个体化、基于机制的护理的转变。我们的分层框架为临床医生和研究人员提供了一个结构化的方法来评估治疗的成熟度和现实世界的适用性。持续研究和仔细解释不断发展的管道和药物的探索性证据是优化长期管理的必要条件。

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Bipolar disorder: Systematic review of approved psychiatric medications (2008–2024) and pipeline Phase-3 medications

Objective

This systematic review evaluates psychiatric medications for bipolar disorder (BP) approved by the U.S. FDA between 2008 and 2024, alongside investigational agents in advanced clinical development, in addition to medications with exploratory evidence. It categorizes these treatments by clinical relevance, mechanism of action, efficacy, dosing, adverse effects, and guideline and real-world use.

Methods

We conducted a systematic search of PubMed, FDALabel, and ClinicalTrials.gov databases for studies published between 2008 and 2024, using keywords including “bipolar” AND “psychopharm*” OR “medic*” OR “pharm*.” Two reviewers independently assessed the resulting publications, resolving any discrepancies through consensus to finalize the studies for inclusion in this review. Key findings from the selected full-text articles were extracted to compile data for the review tables. We also utilized practice guidelines for BP from the US, Canada, the UK, and Australia/New Zealand.

Results

BP medications were categorized into three tiers: (1) FDA-approved and guideline-endorsed, (2) FDA-approved, with emerging clinical use, and (3) Phase 3 agents. We described eight Tier 1 and eight Tier 2 medications that received FDA approval from 2008 to 2024, seven that are actively in pipeline Phase 3 clinical trials, and six more medications with exploratory evidence.

Conclusion

Advances in pharmacologic treatment for bipolar disorder over the past 16 years reflect a shift towards individualized, mechanism-based care. Our tiered framework offers clinicians and researchers a structured approach to evaluate treatment maturity and real-world applicability. Continued research and careful interpretation of the evolving pipeline and medications with exploratory evidence are essential to optimize long-term management.

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来源期刊

Journal of affective disorders 医学-精神病学

CiteScore

10.90

自引率

6.10%

发文量

1319

审稿时长

9.3 weeks

期刊介绍： The Journal of Affective Disorders publishes papers concerned with affective disorders in the widest sense: depression, mania, mood spectrum, emotions and personality, anxiety and stress. It is interdisciplinary and aims to bring together different approaches for a diverse readership. Top quality papers will be accepted dealing with any aspect of affective disorders, including neuroimaging, cognitive neurosciences, genetics, molecular biology, experimental and clinical neurosciences, pharmacology, neuroimmunoendocrinology, intervention and treatment trials.