Recommendations for the pharmacological treatment of treatment-resistant depression: A systematic review protocol

PLOS ONE STUDY PROTOCOL Recommendations for the pharmacological treatment of treatment-resistant depression: A systematic review protocol Franciele Cordeiro Gabriel ID1☯*, Airton Tetelbom Stein2,3☯, Daniela Oliveira de Melo4☯, Géssica Caroline Henrique Fontes-Mota1‡, Itamires Benı́cio dos Santos ID4‡, Camila da Silva Rodrigues4‡, Mônica Cristiane Rodrigues5‡, Renério Fráguas6☯, Ivan D. Florez ID7,8,9☯, Diogo Telles Correia10☯, Eliane Ribeiro ID1☯ a1111111111 a1111111111 a1111111111 a1111111111 a1111111111 OPEN ACCESS Citation: Gabriel FC, Stein AT, de Melo DO, FontesMota GCH, dos Santos IB, Rodrigues CdS, et al. (2022) Recommendations for the pharmacological treatment of treatment-resistant depression: A systematic review protocol. PLoS ONE 17(4): e0267323. https://doi.org/10.1371/journal. pone.0267323 Editor: Maria G. Grammatikopoulou, International Hellenic University: Diethnes Panepistemio tes Ellados, GREECE Received: October 15, 2021 Accepted: April 6, 2022 Published: April 19, 2022 Copyright: © 2022 Gabriel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Funding: Initials of the authors who received each award: FCG Award Number: 141811/2020-0 The full name of each funder: Conselho Nacional de Desenvolvimento Cientı́fico e Tecnológico URL of each funder website: https://www.gov.br/cnpq/ptbr Have or will the sponsors or funders play any role in the study design, data collection (when applicable) and analysis, decision to publish, or preparation of the manuscript? The funders had not and will not have a role in study design, data 1 Departamento de Farmácia, Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, São Paulo, Brasil, 2 Departamento de Saúde Coletiva, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brasil, 3 Curso de Pós-graduação em Avaliação de Tecnologia em Saúde, Hospital Conceição, Porto Alegre, Rio Grande do Sul, Brasil, 4 Departamento de Ciências Farmacêuticas, Instituto de Ciências Ambientais, Quı́micas e Farmacêuticas, Universidade Federal de São Paulo, Diadema, São Paulo, Brasil, 5 Faculdade de Saúde Pública, Universidade de São Paulo, São Paulo, São Paulo, Brasil, 6 Laboratório de Neuro-imagem em Psiquiatria—LIM-21, Departamento e Instituto de Psiquiatria, Hospital das Clı́nicas, Faculdade de Medicina, Universidade de São Paulo, Divisão de Psiquiatria e Psicologia, Hospital Universitário, Universidade de São Paulo, São Paulo, São Paulo, Brasil, 7 School of Rehabilitation Sciences, McMaster University, Hamilton, Ontario, Canada, 8 Department of Pediatrics, University of Antioquia, Medellı́n, Colombia, 9 Pediatric Intensive Care Unit, Clinica Las AmericasAUNA, Medellin, Colombia, 10 Departamento de Psiquiatria e Psicologia da Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal ☯ These authors contributed equally to this work. ‡ GCHF-M, IBS, CSR and MCR also contributed equally to this work. * Abstract Introduction Depression is a serious and widespread mental health disorder. Although effective treatment does exist, a significant proportion of patients with depression fail to respond to antidepressant treatment trials, a condition named treatment-resistant depression. Efficient approach should be given this condition in order to revert the burden caused by depression. Clinical practice guidelines (CPGs) are evidence-based health promotion instruments to improve diagnosis and treatment. CPGs recommendations for treatment-resistant depression must be trustworthy. The objective of the proposed study is to systematically identify, appraise the quality of CPGs for the treatment of depression and elaborate a synthesis of recommendations for treatment-resistant depression of CPGs considered to be of high quality and with high quality recommendations. Methods and analysis We will search the databases of organizations, such as PubMed, Embase, Cochrane Library, PsycInfo, and the Virtual Health Library, and organizations that develop CPGs. Three independent researchers will assess the quality of the CPGs and their recommendations using the AGREE II and AGREE-REX instruments, respectively. Given the PLOS ONE | https://doi.org/10.1371/journal.pone.0267323 April 19, 2022 1 / 10 PLOS ONE Guidelines’ recommendations for resistant depression collection and analysis, decision to publish, or preparation of the manuscript. Initials of the authors who received each award: FCG. identification of divergences and convergences as well as weak and strong points among high quality CPGs, our work may help developers, clinicians and eventually patients. Competing interests: Ivan Florez is the current leader in the AGREE collaboration. All other authors declare that they have no conflicts of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials. Ethics and dissemination No ethical approval is required for a systematic review, as no patient data will be used. The research results will be disseminated in conferences and submitted to a peer reviewed journal. Introduction Depression is a serious medical illness that negatively affects behaviour. This condition causes feelings of sadness and/or loss of interest in everyday life activities. It is also a common condition, which affects more than 300 million people worldwide and is considered one of the most relevant public health problems in the 21st century [1]. Owing to its disabling nature, it can cause various professional, economic, social, and personal losses [2]. Patients with lower response to depression treatment have higher risk of severe outcomes including job loss, isolation, and suicide which may lead to an increased economic cost to society [3]. In addition, over the last years the number of depressed people has increased considerably, overloading health systems and generating a greater need for resource optimization [4]. There are several classes of antidepressants including serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, noradrenergic and serotonergic antidepressants, monoamine oxidase inhibitors, and others, which are effective for medical treatment of depression [5]. Around only one third of patients will remit after a trial with a selective serotonin reuptake inhibitor (SSRI) and only 25% to 27% will remit after a subsequent trial with another antidepressant [6]. Consequently, a significant number of patients —up to 40%—will be treatment-resistant (i.e., failed to remit to at least two antidepressant trials) [6]. Treatment-resistant depression is difficult to manage, and results are usually poor, especially when unstandardized approaches are used [7–10]. In this respect, clinical practice guidelines (CPGs) are a (...truncated)