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.
A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials / Sforzini, L.; Worrell, C.; Kose, M.; Anderson, I. M.; Aouizerate, B.; Arolt, V.; Bauer, M.; Baune, B. T.; Blier, P.; Cleare, A. J.; Cowen, P. J.; Dinan, T. G.; Fagiolini, A.; Ferrier, I. N.; Hegerl, U.; Krystal, A. D.; Leboyer, M.; McAllister-Williams, R. H.; Mcintyre, R. S.; Meyer-Lindenberg, A.; Miller, A. H.; Nemeroff, C. B.; Normann, C.; Nutt, D.; Pallanti, S.; Pani, L.; Penninx, B. W. J. H.; Schatzberg, A. F.; Shelton, R. C.; Yatham, L. N.; Young, A. H.; Zahn, R.; Aislaitner, G.; Butlen-Ducuing, F.; Fletcher, C.; Haberkamp, M.; Laughren, T.; Mantyla, F. -L.; Schruers, K.; Thomson, A.; Arteaga-Henriquez, G.; Benedetti, F.; Cash-Gibson, L.; Chae, W. R.; De Smedt, H.; Gold, S. M.; Hoogendijk, W. J. G.; Mondragon, V. J.; Maron, E.; Martynowicz, J.; Melloni, E.; Otte, C.; Perez-Fuentes, G.; Poletti, S.; Schmidt, M. E.; van de Ketterij, E.; Woo, K.; Flossbach, Y.; Ramos-Quiroga, J. A.; Savitz, A. J.; Pariante, C. M.. - In: MOLECULAR PSYCHIATRY. - ISSN 1359-4184. - (2021), pp. 1-14. [10.1038/s41380-021-01381-x]
A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials
Pani L.;
2021
Abstract
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.
| File | Dimensione | Formato | |
|---|---|---|---|
|
s41380-021-01381-x.pdf
Open access
Tipologia:
Versione pubblicata dall'editore
Dimensione
1.34 MB
Formato
Adobe PDF
|
1.34 MB | Adobe PDF | Visualizza/Apri |
Pubblicazioni consigliate
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris
