Suprani Federico, Paribello Pasquale, Mancini Giulia Federica, Morena Maria, Pinna Marco, Pinna Federica, Contu Martina, Visioli Caterina, Medas Fabio, Canu Gian Luigi, Cappellacci Federico, Calò Pietro Giorgio, Finco Gabriele, Sardo Salvatore, Puligheddu Monica Maria Francesca, D'Aloja Ernesto, Pisanu Claudia, Squassina Alessio, Congiu Donatella, Leggio Gian Marco, Manchia Mirko, Campolongo Patrizia
Section of Psychiatry, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.
Unit of Psychiatry, University Hospital Agency of Cagliari, Cagliari, Italy.
Front Psychiatry. 2025 Jul 30;16:1584583. doi: 10.3389/fpsyt.2025.1584583. eCollection 2025.
Post-Traumatic Stress Disorder (PTSD) is a highly debilitating psychiatric disorder, which develops in a subset of trauma-exposed individuals. Patients with PTSD fail to extinguish fear responses to no-longer dangerous stimuli and develop enduring experiences of fear and anxiety. To advance the understanding of PTSD neurobiology, longitudinal and comprehensive clinical and molecular data are needed. Here we present the protocol of the project "Reli€ving-PTSD" aiming at identifying the molecular signatures of PTSD vulnerability and disease progression in a longitudinal study in humans. The molecular signature will be based on the analysis of the endocannabinoid (eCB) system, as well as miRNome and transcriptome profiles. The study will recruit 60 participants hospitalized in the Intensive Care Unity of the University Hospital Agency of Cagliari. Participants will be eligible for this study if they are: 1) between 18 and 65 years old; 2) able to provide written informed consent. We plan to recruit 30 patients with a diagnosis of PTSD or Acute Stress Disorder (ASD) according to DSM-5 and 30 patients without either diagnosis. Exclusion criteria are: 1) history of traumatic brain injury; 2) current and/or lifetime diagnosis of psychiatric disorders other than PTSD/ASD; 3) current and/or lifetime diagnosis of substance use disorder; 4) presence of severe neurological or medical morbidity. These stringent eligibility criteria will reduce the confounding effect of comorbidities, as molecular alterations of the eCB system have been associated to several psychiatric disorders. This research addresses critical gaps in PTSD management. The outcomes are anticipated to significantly advance scientific knowledge, inform clinical practices, and benefit public health by reducing the societal and economic burden of PTSD through improved precision medicine-based prevention and treatment strategies. The study was reviewed and approved by the Ethics Committee of the Region of Sardinia (Prot. CE/2023_014) and funded by the European Union - Next Generation EU - NRRP M6C2 - Investment 2.1 Enhancement and strengthening of biomedical research in the NHS.
创伤后应激障碍（PTSD）是一种极具致残性的精神障碍，在一部分遭受创伤的个体中出现。PTSD患者无法消除对不再危险的刺激的恐惧反应，并产生持久的恐惧和焦虑体验。为了增进对PTSD神经生物学的理解，需要纵向和全面的临床及分子数据。在此，我们展示了“缓解-PTSD”项目的方案，旨在通过一项针对人类的纵向研究确定PTSD易感性和疾病进展的分子特征。该分子特征将基于对内源性大麻素（eCB）系统以及微小RNA组和转录组图谱的分析。该研究将招募60名在卡利亚里大学医院机构重症监护病房住院的参与者。如果参与者符合以下条件，则有资格参加本研究：1）年龄在18至65岁之间；2）能够提供书面知情同意书。我们计划招募30名根据《精神疾病诊断与统计手册》第5版诊断为PTSD或急性应激障碍（ASD）的患者以及30名未患这两种疾病的患者。排除标准为：1）创伤性脑损伤史；2）目前和/或终生诊断为除PTSD/ASD之外的精神障碍；3）目前和/或终生诊断为物质使用障碍；4）存在严重的神经或医学疾病。这些严格的入选标准将减少合并症的混杂效应，因为eCB系统的分子改变已与多种精神障碍相关。这项研究填补了PTSD管理方面的关键空白。预计研究结果将显著推进科学知识，为临床实践提供信息，并通过改进基于精准医学的预防和治疗策略减轻PTSD的社会和经济负担，从而造福公众健康。该研究已获得撒丁岛地区伦理委员会的审查和批准（协议号：CE/2023_014），并由欧盟-下一代欧盟-NRRP M6C2-投资2.1加强和强化国民保健服务体系中的生物医学研究资助。
