Prospective, observational, single-centre cohort study with an independent control group matched for age and sex aimed at investigating the significance of cholinergic activity in patients with schizophrenia: study protocol of the CLASH-study
Introduction 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 trans...
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BMJ Publishing Group
2021-12-01
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| Series: | BMJ Open |
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| author | Benjamin Mayer Eberhard Barth Benedikt Schick Claire-Louise Weber Theresa Hagemeyer Carlos Schönfeldt-Lecuona |
| author_facet | Benjamin Mayer Eberhard Barth Benedikt Schick Claire-Louise Weber Theresa Hagemeyer Carlos Schönfeldt-Lecuona |
| author_sort | Benjamin Mayer |
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| description | Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number DRKS00023143; Pre-results. |
| format | Article |
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| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-12-01 |
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| spelling | doaj-art-eec26c4344fa4096a56b1aca5d5c85872025-08-20T02:31:17ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-050501Prospective, observational, single-centre cohort study with an independent control group matched for age and sex aimed at investigating the significance of cholinergic activity in patients with schizophrenia: study protocol of the CLASH-studyBenjamin Mayer0Eberhard Barth1Benedikt Schick2Claire-Louise Weber3Theresa Hagemeyer4Carlos Schönfeldt-Lecuona55 Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Baden-Württemberg, GermanyDepartment of Anaesthesiology, University Hospital Ulm, Ulm, GermanyDepartment of Anaesthesiology, University Hospital Ulm, Ulm, GermanyDepartment of Psychiatry and Psychotherapy III, University Hospital Ulm, Ulm, GermanyDepartment of Psychiatry and Psychotherapy III, University Hospital Ulm, Ulm, GermanyDepartment of Psychiatry and Psychotherapy III, University Hospital Ulm, Ulm, GermanyIntroduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number DRKS00023143; Pre-results.https://bmjopen.bmj.com/content/11/12/e050501.full |
| spellingShingle | Benjamin Mayer Eberhard Barth Benedikt Schick Claire-Louise Weber Theresa Hagemeyer Carlos Schönfeldt-Lecuona Prospective, observational, single-centre cohort study with an independent control group matched for age and sex aimed at investigating the significance of cholinergic activity in patients with schizophrenia: study protocol of the CLASH-study BMJ Open |
| title | Prospective, observational, single-centre cohort study with an independent control group matched for age and sex aimed at investigating the significance of cholinergic activity in patients with schizophrenia: study protocol of the CLASH-study |
| title_full | Prospective, observational, single-centre cohort study with an independent control group matched for age and sex aimed at investigating the significance of cholinergic activity in patients with schizophrenia: study protocol of the CLASH-study |
| title_fullStr | Prospective, observational, single-centre cohort study with an independent control group matched for age and sex aimed at investigating the significance of cholinergic activity in patients with schizophrenia: study protocol of the CLASH-study |
| title_full_unstemmed | Prospective, observational, single-centre cohort study with an independent control group matched for age and sex aimed at investigating the significance of cholinergic activity in patients with schizophrenia: study protocol of the CLASH-study |
| title_short | Prospective, observational, single-centre cohort study with an independent control group matched for age and sex aimed at investigating the significance of cholinergic activity in patients with schizophrenia: study protocol of the CLASH-study |
| title_sort | prospective observational single centre cohort study with an independent control group matched for age and sex aimed at investigating the significance of cholinergic activity in patients with schizophrenia study protocol of the clash study |
| url | https://bmjopen.bmj.com/content/11/12/e050501.full |
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