Department of Anaesthesiology, University Hospital Ulm, Ulm, Germany
Department of Anaesthesiology, University Hospital Ulm, Ulm, Germany.
BMJ Open. 2021 Dec 20;11(12):e050501. doi: 10.1136/bmjopen-2021-050501.
Alterations in the cholinergic metabolism may cause various clinical symptoms of schizophrenia. In addition to the 'monoamine hypothesis,' neuroinflammation is also discussed as a cause of schizophrenia. To date, there has been no evidence of alterations in the central cholinergic transmitter balance in patients with schizophrenia under clinical conditions. By contrast, studies in critically ill patients have established the measurement of acetylcholinesterase activity as a suitable surrogate parameter of central cholinergic transmitter balance/possible pathophysiological changes. Butyrylcholinesterase activity has been established as a parameter indicating possible (neuro)inflammatory processes. Both parameters can now be measured using a point-of-care approach. Therefore, the primary objective of this study is to investigate whether acetylcholinesterase and butyrylcholinesterase activity differs in patients with various forms of schizophrenia. Secondary objectives address the possible association between acetylcholinesterase and butyrylcholinesterase activity and (1) schizophrenic symptoms using the Positive and Negative Syndrome Scale, (2) the quantity of antipsychotics taken and (3) the duration of illness.
The study is designed as a prospective, observational cohort study with one independent control group. It is being carried out at the Department of Psychiatry and Psychotherapy III, Ulm University Hospital, Germany. Patient enrolment started in October 2020, and the anticipated end of the study is in January 2022. The enrolment period was set from October 2020 to December 2021 (extension required due to SARS-CoV-2 pandemic). The sample size is calculated at 50 patients in each group. Esterase activity is measured on hospital admission (acute symptomatology) and after referral to a postacute ward over a period of three consecutive days. The matched control group will be created after reaching 50 patients with schizophrenia. This will be followed by a comprehensive statistical analysis of the data set.
The study was registered prospectively in the German Clinical Trials Register (DRKS-ID: DRKS00023143,URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023143) after approval by the ethics committee of the University of Ulm, Germany Trial Code No. 280/20.
DRKS00023143; Pre-results.
胆碱能代谢的改变可能导致精神分裂症的各种临床症状。除了“单胺假说”之外，神经炎症也被认为是精神分裂症的一个病因。迄今为止，在临床情况下，还没有证据表明精神分裂症患者的中枢胆碱能递质平衡发生改变。相比之下，对重症患者的研究已经确立了测量乙酰胆碱酯酶活性作为中枢胆碱能递质平衡/可能的病理生理变化的合适替代参数。丁酰胆碱酯酶活性已被确立为可能的（神经）炎症过程的参数。现在可以使用即时护理方法测量这两个参数。因此，本研究的主要目的是调查不同形式的精神分裂症患者的乙酰胆碱酯酶和丁酰胆碱酯酶活性是否存在差异。次要目标是探讨乙酰胆碱酯酶和丁酰胆碱酯酶活性与（1）阳性和阴性症状量表（PANSS）中的精神分裂症症状、（2）所服用的抗精神病药物的数量和（3）疾病持续时间之间的可能关联。
该研究设计为一项前瞻性、观察性队列研究，设有一个独立的对照组。它在德国乌尔姆大学医院精神病学和心理治疗 III 系进行。患者招募始于 2020 年 10 月，预计研究结束于 2022 年 1 月。招募期为 2020 年 10 月至 2021 年 12 月（由于 SARS-CoV-2 大流行，需要延长时间）。计算得出每组 50 名患者的样本量。入院时（急性症状）和在连续三天转至急性后病房后测量酯酶活性。当达到 50 名精神分裂症患者后，将创建匹配的对照组。然后对数据集进行全面的统计分析。
该研究在德国临床试验注册处（DRKS-ID：DRKS00023143，网址：https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023143）进行了前瞻性注册，此前已获得德国乌尔姆大学伦理委员会的批准，试验代码编号为 280/20。
DRKS00023143；预结果。
