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A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials
Criteria for treatment-resistant depression (TRD) and partially responsive depression (PRD) as subtypes of major depressive disorder (MDD) are not unequivocally defined. In the present document we used a Delphi-method-based consensus approach to define TRD and PRD and to serve as operational criteri...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Nature Publishing Group UK
2021
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9095475/ https://www.ncbi.nlm.nih.gov/pubmed/34907394 http://dx.doi.org/10.1038/s41380-021-01381-x |
| _version_ | 1784705760106643456 |
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| author | Sforzini, Luca Worrell, Courtney Kose, Melisa Anderson, Ian M. Aouizerate, Bruno Arolt, Volker Bauer, Michael Baune, Bernhard T. Blier, Pierre Cleare, Anthony J. Cowen, Philip J. Dinan, Timothy G. Fagiolini, Andrea Ferrier, I. Nicol Hegerl, Ulrich Krystal, Andrew D. Leboyer, Marion McAllister-Williams, R. Hamish McIntyre, Roger S. Meyer-Lindenberg, Andreas Miller, Andrew H. Nemeroff, Charles B. Normann, Claus Nutt, David Pallanti, Stefano Pani, Luca Penninx, Brenda W. J. H. Schatzberg, Alan F. Shelton, Richard C. Yatham, Lakshmi N. Young, Allan H. Zahn, Roland Aislaitner, Georgios Butlen-Ducuing, Florence Fletcher, Christine Haberkamp, Marion Laughren, Thomas Mäntylä, Fanni-Laura Schruers, Koen Thomson, Andrew Arteaga-Henríquez, Gara Benedetti, Francesco Cash-Gibson, Lucinda Chae, Woo Ri De Smedt, Heidi Gold, Stefan M. Hoogendijk, Witte J. G. Mondragón, Valeria Jordán Maron, Eduard Martynowicz, Jadwiga Melloni, Elisa Otte, Christian Perez-Fuentes, Gabriela Poletti, Sara Schmidt, Mark E. van de Ketterij, Edwin Woo, Katherine Flossbach, Yanina Ramos-Quiroga, J. Antoni Savitz, Adam J. Pariante, Carmine M. |
| author_facet | Sforzini, Luca Worrell, Courtney Kose, Melisa Anderson, Ian M. Aouizerate, Bruno Arolt, Volker Bauer, Michael Baune, Bernhard T. Blier, Pierre Cleare, Anthony J. Cowen, Philip J. Dinan, Timothy G. Fagiolini, Andrea Ferrier, I. Nicol Hegerl, Ulrich Krystal, Andrew D. Leboyer, Marion McAllister-Williams, R. Hamish McIntyre, Roger S. Meyer-Lindenberg, Andreas Miller, Andrew H. Nemeroff, Charles B. Normann, Claus Nutt, David Pallanti, Stefano Pani, Luca Penninx, Brenda W. J. H. Schatzberg, Alan F. Shelton, Richard C. Yatham, Lakshmi N. Young, Allan H. Zahn, Roland Aislaitner, Georgios Butlen-Ducuing, Florence Fletcher, Christine Haberkamp, Marion Laughren, Thomas Mäntylä, Fanni-Laura Schruers, Koen Thomson, Andrew Arteaga-Henríquez, Gara Benedetti, Francesco Cash-Gibson, Lucinda Chae, Woo Ri De Smedt, Heidi Gold, Stefan M. Hoogendijk, Witte J. G. Mondragón, Valeria Jordán Maron, Eduard Martynowicz, Jadwiga Melloni, Elisa Otte, Christian Perez-Fuentes, Gabriela Poletti, Sara Schmidt, Mark E. van de Ketterij, Edwin Woo, Katherine Flossbach, Yanina Ramos-Quiroga, J. Antoni Savitz, Adam J. Pariante, Carmine M. |
| author_sort | Sforzini, Luca |
| collection | PubMed |
| description | Criteria for treatment-resistant depression (TRD) and partially responsive depression (PRD) as subtypes of major depressive disorder (MDD) are not unequivocally defined. In the present document we used a Delphi-method-based consensus approach to define TRD and PRD and to serve as operational criteria for future clinical studies, especially if conducted for regulatory purposes. We reviewed the literature and brought together a group of international experts (including clinicians, academics, researchers, employees of pharmaceutical companies, regulatory bodies representatives, and one person with lived experience) to evaluate the state-of-the-art and main controversies regarding the current classification. We then provided recommendations on how to design clinical trials, and on how to guide research in unmet needs and knowledge gaps. This report will feed into one of the main objectives of the EUropean Patient-cEntric clinicAl tRial pLatforms, Innovative Medicines Initiative (EU-PEARL, IMI) MDD project, to design a protocol for platform trials of new medications for TRD/PRD. |
| format | Online Article Text |
| id | pubmed-9095475 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2021 |
| publisher | Nature Publishing Group UK |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-90954752022-05-13 A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials Sforzini, Luca Worrell, Courtney Kose, Melisa Anderson, Ian M. Aouizerate, Bruno Arolt, Volker Bauer, Michael Baune, Bernhard T. Blier, Pierre Cleare, Anthony J. Cowen, Philip J. Dinan, Timothy G. Fagiolini, Andrea Ferrier, I. Nicol Hegerl, Ulrich Krystal, Andrew D. Leboyer, Marion McAllister-Williams, R. Hamish McIntyre, Roger S. Meyer-Lindenberg, Andreas Miller, Andrew H. Nemeroff, Charles B. Normann, Claus Nutt, David Pallanti, Stefano Pani, Luca Penninx, Brenda W. J. H. Schatzberg, Alan F. Shelton, Richard C. Yatham, Lakshmi N. Young, Allan H. Zahn, Roland Aislaitner, Georgios Butlen-Ducuing, Florence Fletcher, Christine Haberkamp, Marion Laughren, Thomas Mäntylä, Fanni-Laura Schruers, Koen Thomson, Andrew Arteaga-Henríquez, Gara Benedetti, Francesco Cash-Gibson, Lucinda Chae, Woo Ri De Smedt, Heidi Gold, Stefan M. Hoogendijk, Witte J. G. Mondragón, Valeria Jordán Maron, Eduard Martynowicz, Jadwiga Melloni, Elisa Otte, Christian Perez-Fuentes, Gabriela Poletti, Sara Schmidt, Mark E. van de Ketterij, Edwin Woo, Katherine Flossbach, Yanina Ramos-Quiroga, J. Antoni Savitz, Adam J. Pariante, Carmine M. Mol Psychiatry Review Article Criteria for treatment-resistant depression (TRD) and partially responsive depression (PRD) as subtypes of major depressive disorder (MDD) are not unequivocally defined. In the present document we used a Delphi-method-based consensus approach to define TRD and PRD and to serve as operational criteria for future clinical studies, especially if conducted for regulatory purposes. We reviewed the literature and brought together a group of international experts (including clinicians, academics, researchers, employees of pharmaceutical companies, regulatory bodies representatives, and one person with lived experience) to evaluate the state-of-the-art and main controversies regarding the current classification. We then provided recommendations on how to design clinical trials, and on how to guide research in unmet needs and knowledge gaps. This report will feed into one of the main objectives of the EUropean Patient-cEntric clinicAl tRial pLatforms, Innovative Medicines Initiative (EU-PEARL, IMI) MDD project, to design a protocol for platform trials of new medications for TRD/PRD. Nature Publishing Group UK 2021-12-15 2022 /pmc/articles/PMC9095475/ /pubmed/34907394 http://dx.doi.org/10.1038/s41380-021-01381-x Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
| spellingShingle | Review Article Sforzini, Luca Worrell, Courtney Kose, Melisa Anderson, Ian M. Aouizerate, Bruno Arolt, Volker Bauer, Michael Baune, Bernhard T. Blier, Pierre Cleare, Anthony J. Cowen, Philip J. Dinan, Timothy G. Fagiolini, Andrea Ferrier, I. Nicol Hegerl, Ulrich Krystal, Andrew D. Leboyer, Marion McAllister-Williams, R. Hamish McIntyre, Roger S. Meyer-Lindenberg, Andreas Miller, Andrew H. Nemeroff, Charles B. Normann, Claus Nutt, David Pallanti, Stefano Pani, Luca Penninx, Brenda W. J. H. Schatzberg, Alan F. Shelton, Richard C. Yatham, Lakshmi N. Young, Allan H. Zahn, Roland Aislaitner, Georgios Butlen-Ducuing, Florence Fletcher, Christine Haberkamp, Marion Laughren, Thomas Mäntylä, Fanni-Laura Schruers, Koen Thomson, Andrew Arteaga-Henríquez, Gara Benedetti, Francesco Cash-Gibson, Lucinda Chae, Woo Ri De Smedt, Heidi Gold, Stefan M. Hoogendijk, Witte J. G. Mondragón, Valeria Jordán Maron, Eduard Martynowicz, Jadwiga Melloni, Elisa Otte, Christian Perez-Fuentes, Gabriela Poletti, Sara Schmidt, Mark E. van de Ketterij, Edwin Woo, Katherine Flossbach, Yanina Ramos-Quiroga, J. Antoni Savitz, Adam J. Pariante, Carmine M. A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials |
| title | A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials |
| title_full | A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials |
| title_fullStr | A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials |
| title_full_unstemmed | A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials |
| title_short | A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials |
| title_sort | delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials |
| topic | Review Article |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9095475/ https://www.ncbi.nlm.nih.gov/pubmed/34907394 http://dx.doi.org/10.1038/s41380-021-01381-x |
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delphimethodbasedconsensusguidelinefordefinitionoftreatmentresistantdepressionforclinicaltrials |