PMID- 28550022 OWN - NLM STAT- MEDLINE DCOM- 20180314 LR - 20190202 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 7 IP - 5 DP - 2017 May 25 TI - Longitudinal assessment of brain-derived neurotrophic factor in Sardinian psychotic patients (LABSP): a protocol for a prospective observational study. PG - e014938 LID - 10.1136/bmjopen-2016-014938 [doi] LID - e014938 AB - INTRODUCTION: Brain-derived neurotrophic factor (BDNF) plays a crucial role in neurodevelopment, synaptic plasticity and neuronal function and survival. Serum and plasma BDNF levels are moderately, but consistently, decreased in patients with schizophrenia (SCZ) compared with healthy controls. There is a lack of knowledge, however, on the temporal manifestation of this decline. Clinical, illness course and treatment factors might influence the variation of BDNF serum levels in patients with psychosis. In this context, we propose a longitudinal study of a cohort of SCZ and schizophrenic and schizoaffective disorder (SAD) Sardinian patients with the aim of disentangling the relationship between peripheral BDNF serum levels and changes of psychopathology, cognition and drug treatments. METHODS AND ANALYSIS: Longitudinal assessment of BDNF in Sardinian psychotic patients (LABSP) is a 24-month observational prospective cohort study. Patients with SAD will be recruited at the Psychiatry Research Unit of the Department of Medical Science and Public Health, University of Cagliari and University of Cagliari Health Agency, Cagliari, Italy. We will collect BDNF serum levels as well as sociodemographic, psychopathological and neurocognitive measures. Structured, semistructured and self-rating assessment tools, such as the Positive and Negative Syndrome Scale for psychopathological measures and the Brief Assessment of Cognition in Schizophrenia for cognitive function, will be used. ETHICS AND DISSEMINATION: This study protocol was approved by the University of Cagliari Health Agency Ethics Committee (NP2016/5491). The study will be conducted in accordance with the principles of good clinical practice, in the Declaration of Helsinki in compliance with the regulations. Participation will be voluntary and written informed consent will be obtained for each participant upon entry into the study. We plan to disseminate the results of our study through conference presentations and publication in international peer-reviewed journals. Access to raw data will be available in anonymised form upon request to the corresponding author. CI - (c) Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. FAU - Primavera, Diego AU - Primavera D AD - Section of Psychiatry, Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy. FAU - Manchia, Mirko AU - Manchia M AUID- ORCID: 0000-0003-4175-6413 AD - Section of Psychiatry, Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy. AD - Department of Pharmacology, Dalhousie University, Halifax, Canada. FAU - Deriu, Luca AU - Deriu L AD - Section of Psychiatry, Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy. FAU - Tusconi, Massimo AU - Tusconi M AUID- ORCID: 0000-0002-9155-4740 AD - Section of Psychiatry, Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy. FAU - Collu, Roberto AU - Collu R AD - Department of Biomedical Sciences, Division of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy. FAU - Scherma, Maria AU - Scherma M AD - Department of Biomedical Sciences, Division of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy. FAU - Fadda, Paola AU - Fadda P AD - Department of Biomedical Sciences, Division of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy. AD - Centre of Excellence 'Neurobiology of Dependence', University of Cagliari, Cagliari, Italy. FAU - Fratta, Walter AU - Fratta W AD - Department of Biomedical Sciences, Division of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy. AD - Centre of Excellence 'Neurobiology of Dependence', University of Cagliari, Cagliari, Italy. FAU - Carpiniello, Bernardo AU - Carpiniello B AD - Section of Psychiatry, Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy. LA - eng PT - Journal Article PT - Observational Study DEP - 20170525 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 RN - 0 (Antipsychotic Agents) RN - 0 (Biomarkers) RN - 0 (Brain-Derived Neurotrophic Factor) RN - 7171WSG8A2 (BDNF protein, human) SB - IM MH - Adult MH - Antipsychotic Agents/*therapeutic use MH - Biomarkers/blood MH - Brain-Derived Neurotrophic Factor/*blood MH - Clinical Protocols MH - Cognition/drug effects/*physiology MH - Extrapyramidal Tracts/physiopathology MH - Female MH - Humans MH - Italy MH - Longitudinal Studies MH - Male MH - Middle Aged MH - Neuropsychological Tests MH - Prognosis MH - Prospective Studies MH - Psychotic Disorders/*blood/*drug therapy/physiopathology MH - Severity of Illness Index MH - Young Adult PMC - PMC5729982 OTO - NOTNLM OT - Antipsychotics OT - BDNF OT - Prospective study OT - Schizophrenia & psychotic disorders COIS- Competing interests: None declared. EDAT- 2017/05/28 06:00 MHDA- 2018/03/15 06:00 PMCR- 2017/05/25 CRDT- 2017/05/28 06:00 PHST- 2017/05/28 06:00 [entrez] PHST- 2017/05/28 06:00 [pubmed] PHST- 2018/03/15 06:00 [medline] PHST- 2017/05/25 00:00 [pmc-release] AID - bmjopen-2016-014938 [pii] AID - 10.1136/bmjopen-2016-014938 [doi] PST - epublish SO - BMJ Open. 2017 May 25;7(5):e014938. doi: 10.1136/bmjopen-2016-014938.