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Bridging the reporting gap: Application of the ReSPCT guidelines in psilocybin clinical trial protocols 弥合报告差距:ReSPCT指南在裸盖菇素临床试验方案中的应用
IF 6.7 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-01-16 DOI: 10.1016/j.euroneuro.2025.112746
Damian Swieczkowski , Aleksander Kwaśny , Krzysztof Sadko , Wiesław Jerzy Cubała
Psilocybin-assisted therapies are increasingly studied for Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD), and methodological rigor requires both pharmacological evaluation and consistent reporting of non-pharmacological variables that influence therapeutic outcomes. To address this need, the ReSPCT (Reporting of Setting in Psychedelic Clinical Trials) guidelines were recently introduced, providing a 30-item framework for standardized reporting of set and setting. This study aimed to evaluate how current psilocybin clinical trial protocols incorporate these elements and to identify domains requiring improvement. We systematically searched ClinicalTrials.gov and the EU Clinical Trials Information System (CTIS) for interventional psilocybin studies targeting MDD or TRD, including protocols listing depression as a primary condition. By June 21, 2025, 13 protocols (11 Phase II and 2 Phase III) met the inclusion criteria. Each protocol was assessed using the ReSPCT checklist, yielding a total of 390 item-level assessments rated on a four-point scale. Overall, 61 of 390 entries (15.6%) demonstrated full compliance, 252 (64.6%) partial compliance, and 77 (19.7%) provided no relevant information. Procedural elements, such as medical and experimental procedures (100% compliance), focus and main activities (92.3%), number of sessions (69.2%), and dosing regimens (53.8%), were consistently reported. In contrast, contextual and equity-related domains were markedly underreported: 84.6% of protocols lacked information on cultural competence and safety, 92.3% did not describe objects or decorations, and 84.6% failed to report access to nature. These findings indicate that while procedural safeguards are well documented, critical contextual and equity-relevant aspects remain insufficiently reported. Adopting ReSPCT guidelines may improve transparency and reproducibility.
对裸盖菇素辅助治疗重度抑郁症(MDD)和难治性抑郁症(TRD)的研究越来越多,方法的严密性要求药理学评估和影响治疗结果的非药理学变量的一致报告。为了满足这一需求,最近引入了《致幻剂临床试验环境报告》(ReSPCT)指南,为环境和环境的标准化报告提供了30个项目的框架。本研究旨在评估当前裸盖菇素临床试验方案如何纳入这些要素,并确定需要改进的领域。我们系统地检索了ClinicalTrials.gov和EU临床试验信息系统(CTIS),寻找针对重度抑郁症或TRD的裸盖菇素干预性研究,包括将抑郁症列为主要疾病的方案。截至2025年6月21日,13个方案(11个II期和2个III期)符合纳入标准。使用ReSPCT检查表对每个方案进行评估,共产生390个项目级评估,按4分制评分。总体而言,390个条目中有61个(15.6%)完全符合要求,252个(64.6%)部分符合要求,77个(19.7%)没有提供相关信息。程序要素,如医疗和实验程序(100%遵守)、重点和主要活动(92.3%)、疗程数(69.2%)和给药方案(53.8%),均得到一致报告。相比之下,上下文和公平相关的领域明显被低估:84.6%的协议缺乏文化能力和安全的信息,92.3%的协议没有描述物体或装饰,84.6%的协议没有报告对自然的获取。这些调查结果表明,虽然程序性保障有充分的文件记录,但关键的背景和与公平有关的方面仍然没有得到充分报告。采用尊重准则可以提高透明度和可重复性。
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引用次数: 0
Child and maternal hair oxytocin: A novel biomarker of dyadic emotional availability 儿童和母亲的头发催产素:一种新的二元情绪可用性生物标志物
IF 6.7 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-01-16 DOI: 10.1016/j.euroneuro.2026.112763
Liat Zelikovich Moyal, Tamar Kadosh-Laor, Laure D. Sultan, Liat Israeli-Ran, Florina Uzefovsky
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引用次数: 0
Biomarker innovations in precision psychiatry diagnostics and treatment strategies 精准精神病学诊断和治疗策略的生物标志物创新
IF 6.7 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-01-15 DOI: 10.1016/j.euroneuro.2026.112762
Martien J.H. Kas , Kim Q. Do , Michael S. Sand , Rouba Kozak , Elizabeth M. Tunbridge , Maria A. Oquendo , Carol Tamminga , Nikolaos Koutsouleris , Gitte Moos Knudsen , Brenda W.J.H. Penninx , Frank J. Padberg , Wayne C. Drevets , Peter Falkai , Derek L. Buhl , Andreas Reif
Precision psychiatry is an approach designed to improve diagnosis and treatment of mental disorders by leveraging biological insights and developing innovative, mechanism-based treatment strategies unconstrained by current diagnostic boundaries. At its core, precision psychiatry aims to pinpoint the underlying neurobiological mechanisms responsible for the emergence and persistence of symptoms of mental health conditions. This approach strives to create diagnostic tools and therapies targeting these mechanisms, potentially addressing previously resistant aspects of mental health conditions by providing more precise symptom management and possibly altering the disease trajectory. Although still in its nascent stages, the realization of precision psychiatry will result in a more refined and biology-informed diagnostic system for mental disorders, requiring significant adaptations for clinicians, industry, patients and regulators. Identifying, validating and applying both fluid and functional biomarkers are critical steps in the development, testing and application of new precision psychiatry diagnostics and treatments. As part of the 2025 Precision Psychiatry Roadmap initiative meeting in Frankfurt, experts came together to present and discuss the current status of biomarker identification and validation, patient subtyping, and targeted interventions for stratified patient groups. This report features lecture summaries, meeting outcomes, and recommendations from both online and in-person audiences. In general, the recommendations emphasize standardization, collaboration, clinical implementation, digital innovation, long-term planning, and, importantly, patient engagement, as key priorities for advancing precision psychiatry. Despite existing challenges, there is strong optimism for the future of precision psychiatry, with continuous efforts to refine diagnostic tools and treatment strategies.
精确精神病学是一种旨在通过利用生物学见解和开发创新的、基于机制的治疗策略来改善精神障碍的诊断和治疗的方法,不受当前诊断界限的限制。精确精神病学的核心是查明导致精神健康状况症状出现和持续的潜在神经生物学机制。这种方法致力于创造针对这些机制的诊断工具和治疗方法,通过提供更精确的症状管理和可能改变疾病轨迹,潜在地解决以前精神健康状况的抗性方面。尽管精确精神病学仍处于起步阶段,但它的实现将导致一个更精细、更了解生物学的精神障碍诊断系统,这需要临床医生、行业、患者和监管机构做出重大调整。识别、验证和应用流体和功能性生物标志物是开发、测试和应用新的精确精神病学诊断和治疗的关键步骤。作为2025年法兰克福精准精神病学路线图倡议会议的一部分,专家们齐聚一堂,介绍并讨论了生物标志物识别和验证、患者亚型和分层患者群体靶向干预的现状。本报告包括讲座总结、会议成果以及来自在线和现场听众的建议。总的来说,这些建议强调标准化、协作、临床实施、数字创新、长期规划,以及更重要的是,患者参与,作为推进精准精神病学的关键优先事项。尽管存在挑战,但随着不断完善诊断工具和治疗策略的努力,人们对精准精神病学的未来抱有强烈的乐观态度。
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引用次数: 0
Response to the letter regarding “Default mode network integrity across neuropsychiatric disorders and its relation to social dysfunction: A normative modelling approach” 对“神经精神疾病的默认模式网络完整性及其与社会功能障碍的关系:一种规范的建模方法”的回复
IF 6.7 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-01-15 DOI: 10.1016/j.euroneuro.2026.112764
Simon Braak , Martien J.H. Kas , Brenda W.J.H. Penninx
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引用次数: 0
Epigenetic Clocks: An emerging role for Biomarkers of Aging in Psychiatry 表观遗传时钟:精神病学中衰老生物标志物的新角色
IF 6.7 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-01-07 DOI: 10.1016/j.euroneuro.2025.112749
Alba Navarro-Flores , Anthony S. Zannas
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引用次数: 0
Risk of schizophrenia-spectrum disorders among individuals with eating disorders: a nation-wide cohort study 饮食失调患者患精神分裂症谱系障碍的风险:一项全国性队列研究。
IF 6.7 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2026-01-07 DOI: 10.1016/j.euroneuro.2025.112748
Adam F. Kemp , Simon Anhøj , Anna Mejldal , Peter N. Schøler , Rikke Wesselhoeft , Maria M. Guala , Christoph U. Correll , Marco Solmi , Angelina I. Mellentin , Mikkel Højlund
Individuals with eating disorders (EDs) hold an increased risk of developing schizophrenia-spectrum disorders (SSDs). It is however unclear whether this applies to all ED subgroups. We conducted a nationwide register-based cohort study including all individuals diagnosed with EDs in Denmark between 01jan1994 and 31dec2015. We used Cox regression models to compare the risk of SSDs between individuals with and without EDs and how this risk was influenced by risk factors and time since diagnosis of ED. The cohort included 20,045 individuals with EDs and 79,720 without ED (median age [interquartile range]:19 [16–24] years; 93% female). During 1,123,372 person-years of follow-up, 1,335 (6.7%) individuals with EDs were diagnosed with SSDs, compared to 982 (1.2%) individuals without EDs. This reflected a 4-fold higher risk of any SSD among individuals with EDs (adjusted hazard ratio [aHR] 4.43; 95% confidence interval [95%CI] 4.04–4.84). Individuals with anorexia nervosa (aHR 4.56 [3.99–5.22]) and other EDs (aHR 4.99 [4.27–5.83]) had a higher risk of any SSD diagnosis compared to individuals with bulimia nervosa (aHR 3.46 [2.83–4.22]). History of previous psychiatric hospitalisation, substance abuse, alcohol abuse, male sex, and onset of ED <19 years were associated with increased risk of SSDs in individuals with EDs. The risk of any SSD diagnosis decreased over time, but persisted ≥11 years after ED diagnosis (aHR 2.23 [1.71–2.92]). In conclusion, individuals with EDs have a four-fold higher risk of developing SSDs, compared with individuals without EDs. Anorexia nervosa and other EDs entails a higher risk of a subsequent SSD diagnosis compared with bulimia nervosa.
患有饮食失调(EDs)的人患精神分裂症谱系障碍(ssd)的风险更高。然而,尚不清楚这是否适用于所有ED亚组。我们在1994年1月1日至2015年12月31日期间在丹麦进行了一项全国性的基于登记的队列研究,包括所有被诊断为ed的个体。我们使用Cox回归模型来比较有ED和没有ED的个体之间的ssd风险,以及这种风险如何受到危险因素和ED诊断后时间的影响。该队列包括20,045例ED患者和79,720例无ED患者(中位年龄[四分位数间距]:19[16-24]岁;93%为女性)。在1123372人年的随访中,1335名(6.7%)ed患者被诊断为ssd,而982名(1.2%)无ed患者被诊断为ssd。这反映出EDs患者发生任何SSD的风险高出4倍(调整后的风险比[aHR] 4.43; 95%可信区间[95% ci] 4.04-4.84)。神经性厌食症(aHR 4.56[3.99-5.22])和其他ed (aHR 4.99[4.27-5.83])的任何SSD诊断风险高于神经性贪食症(aHR 3.46[2.83-4.22])。既往精神科住院史、药物滥用、酒精滥用、男性和ED发作史
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引用次数: 0
Commentary on the Article “Default mode network integrity across neuropsychiatric disorders and its relation to social dysfunction: A normative modelling approach” 对文章“神经精神疾病的默认模式网络完整性及其与社会功能障碍的关系:一种规范的建模方法”的评论
IF 6.7 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-12-27 DOI: 10.1016/j.euroneuro.2025.112743
Yang Liu
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引用次数: 0
Brain 5-HT4 receptor, gastrointestinal symptoms, and SSRI-related nausea in depression 抑郁症患者脑5-HT4受体、胃肠道症状和ssri相关恶心
IF 6.7 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-12-27 DOI: 10.1016/j.euroneuro.2025.112744
K.G. Nielsen , K. Köhler-Forsberg , M.B. Jørgensen , V.G. Froekjaer , K.H.R. Jensen
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引用次数: 0
From first-episode psychosis to the future: Insights and challenges 从首发精神病到未来:洞察与挑战。
IF 6.7 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-12-24 DOI: 10.1016/j.euroneuro.2025.11.008
Ana Catalán , Paolo Fusar-Poli
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引用次数: 0
Prescribing clozapine to 10% of patients with schizophrenia may save 320,000 lives and cost 2400 deaths from agranulocytosis 给10%的精神分裂症患者开氯氮平可以挽救32万人的生命,并使2400人死于粒细胞缺乏症。
IF 6.7 2区 医学 Q1 CLINICAL NEUROLOGY Pub Date : 2025-12-23 DOI: 10.1016/j.euroneuro.2025.112747
Jose de Leon
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引用次数: 0
期刊
European Neuropsychopharmacology
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