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

L. Sforzini; C. Worrell; M. Kose; I.M. Anderson; B. Aouizerate; V. Arolt; M. Bauer; B.T. Baune; P. Blier; A.J. Cleare; P.J. Cowen; T.G. Dinan; A. Fagiolini; I.N. Ferrier; U. Hegerl; A.D. Krystal; M. Leboyer; R.H. McAllister-Williams; R.S. McIntyre; A. Meyer-Lindenberg; A.H. Miller; C.B. Nemeroff; C. Normann; D. Nutt; S. Pallanti; L. Pani; B.W.J.H. Penninx; A.F. Schatzberg; R.C. Shelton; L.N. Yatham; A.H. Young; R. Zahn; G. Aislaitner; F. Butlen-Ducuing; C. Fletcher; M. Haberkamp; T. Laughren; F.L. Mantyla; K. Schruers; A. Thomson; G. Arteaga-Henriquez; F. Benedetti; L. Cash-Gibson; W.R. Chae; H. De Smedt; S.M. Gold; W.J.G. Hoogendijk; V.J. Mondragon; E. Maron; J. Martynowicz

doi:10.1038/s41380-021-01381-x

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

L. Sforzini^*, C. Worrell, M. Kose, I.M. Anderson, B. Aouizerate, V. Arolt, M. Bauer, B.T. Baune, P. Blier, A.J. Cleare, P.J. Cowen, T.G. Dinan, A. Fagiolini, I.N. Ferrier, U. Hegerl, A.D. Krystal, M. Leboyer, R.H. McAllister-Williams, R.S. McIntyre, A. Meyer-LindenbergA.H. Miller, C.B. Nemeroff, C. Normann, D. Nutt, S. Pallanti, L. Pani, B.W.J.H. Penninx, A.F. Schatzberg, R.C. Shelton, L.N. Yatham, A.H. Young, R. Zahn, G. Aislaitner, F. Butlen-Ducuing, C. Fletcher, M. Haberkamp, T. Laughren, F.L. Mantyla, K. Schruers, A. Thomson, G. Arteaga-Henriquez, F. Benedetti, L. Cash-Gibson, W.R. Chae, H. De Smedt, S.M. Gold, W.J.G. Hoogendijk, V.J. Mondragon, E. Maron, J. Martynowicz

^*Corresponding author for this work

Research output: Contribution to journal › (Systematic) Review article › peer-review

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
Pages (from-to)	1286-1299
Number of pages	14
Journal	Molecular Psychiatry
Volume	27
Issue number	3
Early online date	15 Dec 2021
DOIs	https://doi.org/10.1038/s41380-021-01381-x
Publication status	Published - Mar 2022

Keywords

SEROTONIN REUPTAKE INHIBITORS
STAR-ASTERISK-D
REPORT QIDS-SR
QUICK INVENTORY
RATING-SCALE
DISORDER
METAANALYSIS
REMISSION
SYMPTOMATOLOGY
STIMULATION

Access to Document

10.1038/s41380-021-01381-xLicence: CC BY

Cite this

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., ... Martynowicz, J. (2022). A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials. Molecular Psychiatry, 27(3), 1286-1299. https://doi.org/10.1038/s41380-021-01381-x

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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.",

keywords = "SEROTONIN REUPTAKE INHIBITORS, STAR-ASTERISK-D, REPORT QIDS-SR, QUICK INVENTORY, RATING-SCALE, DISORDER, METAANALYSIS, REMISSION, SYMPTOMATOLOGY, STIMULATION",

author = "L. Sforzini and C. Worrell and M. Kose and I.M. Anderson and B. Aouizerate and V. Arolt and M. Bauer and B.T. Baune and P. Blier and A.J. Cleare and P.J. Cowen and T.G. Dinan and A. Fagiolini and I.N. Ferrier and U. Hegerl and A.D. Krystal and M. Leboyer and R.H. McAllister-Williams and R.S. McIntyre and A. Meyer-Lindenberg and A.H. Miller and C.B. Nemeroff and C. Normann and D. Nutt and S. Pallanti and L. Pani and B.W.J.H. Penninx and A.F. Schatzberg and R.C. Shelton and L.N. Yatham and A.H. Young and R. Zahn and G. Aislaitner and F. Butlen-Ducuing and C. Fletcher and M. Haberkamp and T. Laughren and F.L. Mantyla and K. Schruers and A. Thomson and G. Arteaga-Henriquez and F. Benedetti and L. Cash-Gibson and W.R. Chae and {De Smedt}, H. and S.M. Gold and W.J.G. Hoogendijk and V.J. Mondragon and E. Maron and J. Martynowicz",

year = "2022",

month = mar,

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

language = "English",

volume = "27",

pages = "1286--1299",

journal = "Molecular Psychiatry",

issn = "1359-4184",

publisher = "Nature Publishing Group",

number = "3",

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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, Mantyla, FL, Schruers, K, Thomson, A, Arteaga-Henriquez, G, Benedetti, F, Cash-Gibson, L, Chae, WR, De Smedt, H, Gold, SM, Hoogendijk, WJG, Mondragon, VJ, Maron, E & Martynowicz, J 2022, 'A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials', Molecular Psychiatry, vol. 27, no. 3, pp. 1286-1299. 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, L.

AU - Worrell, C.

AU - Kose, M.

AU - Anderson, I.M.

AU - Aouizerate, B.

AU - Arolt, V.

AU - Bauer, M.

AU - Baune, B.T.

AU - Blier, P.

AU - Cleare, A.J.

AU - Cowen, P.J.

AU - Dinan, T.G.

AU - Fagiolini, A.

AU - Ferrier, I.N.

AU - Hegerl, U.

AU - Krystal, A.D.

AU - Leboyer, M.

AU - McAllister-Williams, R.H.

AU - McIntyre, R.S.

AU - Meyer-Lindenberg, A.

AU - Miller, A.H.

AU - Nemeroff, C.B.

AU - Normann, C.

AU - Nutt, D.

AU - Pallanti, S.

AU - Pani, L.

AU - Penninx, B.W.J.H.

AU - Schatzberg, A.F.

AU - Shelton, R.C.

AU - Yatham, L.N.

AU - Young, A.H.

AU - Zahn, R.

AU - Aislaitner, G.

AU - Butlen-Ducuing, F.

AU - Fletcher, C.

AU - Haberkamp, M.

AU - Laughren, T.

AU - Mantyla, F.L.

AU - Schruers, K.

AU - Thomson, A.

AU - Arteaga-Henriquez, G.

AU - Benedetti, F.

AU - Cash-Gibson, L.

AU - Chae, W.R.

AU - De Smedt, H.

AU - Gold, S.M.

AU - Hoogendijk, W.J.G.

AU - Mondragon, V.J.

AU - Maron, E.

AU - Martynowicz, J.

PY - 2022/3

Y1 - 2022/3

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.

KW - SEROTONIN REUPTAKE INHIBITORS

KW - STAR-ASTERISK-D

KW - REPORT QIDS-SR

KW - QUICK INVENTORY

KW - RATING-SCALE

KW - DISORDER

KW - METAANALYSIS

KW - REMISSION

KW - SYMPTOMATOLOGY

KW - STIMULATION

U2 - 10.1038/s41380-021-01381-x

DO - 10.1038/s41380-021-01381-x

M3 - (Systematic) Review article

C2 - 34907394

SN - 1359-4184

VL - 27

SP - 1286

EP - 1299

JO - Molecular Psychiatry

JF - Molecular Psychiatry

IS - 3

ER -