A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials

Luca Sforzini; Courtney Worrell; Melisa Kose; Ian M Anderson; Bruno Aouizerate; Volker Arolt; Michael Bauer; Bernhard T Baune; Pierre Blier; Anthony J Cleare; Philip J Cowen; Timothy G Dinan; Andrea Fagiolini; I Nicol Ferrier; Ulrich Hegerl; Andrew D Krystal; Marion Leboyer; R Hamish McAllister-Williams; Roger S McIntyre; Andreas Meyer-Lindenberg; Andrew H Miller; Charles B Nemeroff; Claus Normann; David Nutt; Stefano Pallanti; Luca Pani; Brenda W J H Penninx; Alan F Schatzberg; Richard C Shelton; Lakshmi N Yatham; Allan H Young; Roland Zahn; Georgios Aislaitner; Florence Butlen-Ducuing; Christine Fletcher; Marion Haberkamp; Thomas Laughren; Fanni-Laura Mäntylä; Koen Schruers; Andrew Thomson; Gara Arteaga-Henríquez; Francesco Benedetti; Lucinda Cash-Gibson; Woo Ri Chae; Heidi De Smedt; Stefan M Gold; Witte J G Hoogendijk; Valeria Jordán Mondragón; Eduard Maron; Carmine M Pariante

doi:10.1038/s41380-021-01381-x

A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials

Luca Sforzini, Courtney Worrell, Melisa Kose, Ian M Anderson, Bruno Aouizerate, Volker Arolt, Michael Bauer, Bernhard T Baune, Pierre Blier, Anthony J Cleare, Philip J Cowen, Timothy G Dinan, Andrea Fagiolini, I Nicol Ferrier, Ulrich Hegerl, Andrew D Krystal, Marion Leboyer, R Hamish McAllister-Williams, Roger S McIntyre, Andreas Meyer-LindenbergAndrew H Miller, Charles B Nemeroff, Claus Normann, David Nutt, Stefano Pallanti, Luca Pani, Brenda W J H Penninx, Alan F Schatzberg, Richard C Shelton, Lakshmi N Yatham, Allan H Young, Roland Zahn, Georgios Aislaitner, Florence Butlen-Ducuing, Christine Fletcher, Marion Haberkamp, Thomas Laughren, Fanni-Laura Mäntylä, Koen Schruers, Andrew Thomson, Gara Arteaga-Henríquez, Francesco Benedetti, Lucinda Cash-Gibson, Woo Ri Chae, Heidi De Smedt, Stefan M Gold, Witte J G Hoogendijk, Valeria Jordán Mondragón, Eduard Maron, Carmine M Pariante

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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.

Original language	English
Journal	Molecular Psychiatry
Early online date	15 Dec 2021
DOIs	https://doi.org/10.1038/s41380-021-01381-x
Publication status	Published - 15 Dec 2021

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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., ... Pariante, C. M. (2021). A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials. Molecular Psychiatry. https://doi.org/10.1038/s41380-021-01381-x

@article{ba33405a75c345dab61b575203268532,

title = "A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials",

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.",

author = "Luca Sforzini and Courtney Worrell and Melisa Kose and Anderson, {Ian M} and Bruno Aouizerate and Volker Arolt and Michael Bauer and Baune, {Bernhard T} and Pierre Blier and Cleare, {Anthony J} and Cowen, {Philip J} and Dinan, {Timothy G} and Andrea Fagiolini and Ferrier, {I Nicol} and Ulrich Hegerl and Krystal, {Andrew D} and Marion Leboyer and McAllister-Williams, {R Hamish} and McIntyre, {Roger S} and Andreas Meyer-Lindenberg and Miller, {Andrew H} and Nemeroff, {Charles B} and Claus Normann and David Nutt and Stefano Pallanti and Luca Pani and Penninx, {Brenda W J H} and Schatzberg, {Alan F} and Shelton, {Richard C} and Yatham, {Lakshmi N} and Young, {Allan H} and Roland Zahn and Georgios Aislaitner and Florence Butlen-Ducuing and Christine Fletcher and Marion Haberkamp and Thomas Laughren and Fanni-Laura M{\"a}ntyl{\"a} and Koen Schruers and Andrew Thomson and Gara Arteaga-Henr{\'i}quez and Francesco Benedetti and Lucinda Cash-Gibson and Chae, {Woo Ri} and {De Smedt}, Heidi and Gold, {Stefan M} and Hoogendijk, {Witte J G} and Mondrag{\'o}n, {Valeria Jord{\'a}n} and Eduard Maron and Pariante, {Carmine M}",

note = "Funding Information: The EU-PEARL Project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853966. The JU receives support from the European Union{\textquoteright}s Horizon 2020 research and innovation programme and EFPIA and CHILDREN{\textquoteright}S TUMOR FOUNDATION, GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT NON-PROFIT ORGANISATION, SPRINGWORKS THERAPEUTICS INC. Publisher Copyright: {\textcopyright} 2021, The Author(s).",

year = "2021",

month = dec,

day = "15",

doi = "10.1038/s41380-021-01381-x",

language = "English",

journal = "Molecular Psychiatry",

issn = "1359-4184",

publisher = "Springer Nature [academic journals on nature.com]",

}

Sforzini, L , Worrell, C , Kose, M, Anderson, IM, Aouizerate, B, Arolt, V, Bauer, M, Baune, BT, Blier, P, Cleare, AJ, Cowen, PJ, Dinan, TG, Fagiolini, A, Ferrier, IN, Hegerl, U, Krystal, AD, Leboyer, M, McAllister-Williams, RH, McIntyre, RS, Meyer-Lindenberg, A, Miller, AH, Nemeroff, CB, Normann, C, Nutt, D, Pallanti, S, Pani, L, Penninx, BWJH, Schatzberg, AF, Shelton, RC, Yatham, LN, Young, AH , Zahn, R, Aislaitner, G, Butlen-Ducuing, F, Fletcher, C, Haberkamp, M, Laughren, T, Mäntylä, F-L, Schruers, K, Thomson, A, Arteaga-Henríquez, G, Benedetti, F, Cash-Gibson, L, Chae, WR, De Smedt, H, Gold, SM, Hoogendijk, WJG, Mondragón, VJ, Maron, E & Pariante, CM 2021, 'A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials', Molecular Psychiatry. https://doi.org/10.1038/s41380-021-01381-x

TY - JOUR

T1 - A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials

AU - Sforzini, Luca

AU - Worrell, Courtney

AU - Kose, Melisa

AU - Anderson, Ian M

AU - Aouizerate, Bruno

AU - Arolt, Volker

AU - Bauer, Michael

AU - Baune, Bernhard T

AU - Blier, Pierre

AU - Cleare, Anthony J

AU - Cowen, Philip J

AU - Dinan, Timothy G

AU - Fagiolini, Andrea

AU - Ferrier, I Nicol

AU - Hegerl, Ulrich

AU - Krystal, Andrew D

AU - Leboyer, Marion

AU - McAllister-Williams, R Hamish

AU - McIntyre, Roger S

AU - Meyer-Lindenberg, Andreas

AU - Miller, Andrew H

AU - Nemeroff, Charles B

AU - Normann, Claus

AU - Nutt, David

AU - Pallanti, Stefano

AU - Pani, Luca

AU - Penninx, Brenda W J H

AU - Schatzberg, Alan F

AU - Shelton, Richard C

AU - Yatham, Lakshmi N

AU - Young, Allan H

AU - Zahn, Roland

AU - Aislaitner, Georgios

AU - Butlen-Ducuing, Florence

AU - Fletcher, Christine

AU - Haberkamp, Marion

AU - Laughren, Thomas

AU - Mäntylä, Fanni-Laura

AU - Schruers, Koen

AU - Thomson, Andrew

AU - Arteaga-Henríquez, Gara

AU - Benedetti, Francesco

AU - Cash-Gibson, Lucinda

AU - Chae, Woo Ri

AU - De Smedt, Heidi

AU - Gold, Stefan M

AU - Hoogendijk, Witte J G

AU - Mondragón, Valeria Jordán

AU - Maron, Eduard

AU - Pariante, Carmine M

N1 - Funding Information: The EU-PEARL Project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853966. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and CHILDREN’S TUMOR FOUNDATION, GLOBAL ALLIANCE FOR TB DRUG DEVELOPMENT NON-PROFIT ORGANISATION, SPRINGWORKS THERAPEUTICS INC. Publisher Copyright: © 2021, The Author(s).

PY - 2021/12/15

Y1 - 2021/12/15

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85121294632&partnerID=8YFLogxK

U2 - 10.1038/s41380-021-01381-x

DO - 10.1038/s41380-021-01381-x

M3 - Article

C2 - 34907394

SN - 1359-4184

JO - Molecular Psychiatry

JF - Molecular Psychiatry

ER -

A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials

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