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

被引：132

作者：

Sforzini, Luca ^{[1
]}

Worrell, Courtney ^{[1
]}

Kose, Melisa ^{[1
]}

Anderson, Ian M. ^{[2
,3
]}

Aouizerate, Bruno ^{[4
]}

Arolt, Volker ^{[5
,6
]}

Bauer, Michael ^{[7
]}

Baune, Bernhard T. ^{[5
,8
,9
]}

Blier, Pierre ^{[10
,11
,12
]}

Cleare, Anthony J. ^{[1
,13
,14
]}

Cowen, Philip J. ^{[15
]}

Dinan, Timothy G. ^{[16
,17
]}

Fagiolini, Andrea ^{[18
]}

Ferrier, I. Nicol ^{[19
]}

Hegerl, Ulrich ^{[20
,21
]}

Krystal, Andrew D. ^{[22
,23
]}

Leboyer, Marion ^{[24
]}

McAllister-Williams, R. Hamish ^{[19
,25
]}

McIntyre, Roger S. ^{[26
,27
,28
,29
]}

Meyer-Lindenberg, Andreas ^{[30
]}

Miller, Andrew H. ^{[31
]}

Nemeroff, Charles B. ^{[32
]}

Normann, Claus ^{[33
]}

Nutt, David ^{[34
]}

Pallanti, Stefano ^{[35
,36
]}

Pani, Luca ^{[37
,38
,39
]}

Penninx, Brenda W. J. H. ^{[40
,41
]}

Schatzberg, Alan F. ^{[42
]}

Shelton, Richard C. ^{[43
]}

Yatham, Lakshmi N. ^{[44
]}

Young, Allan H. ^{[1
,13
,14
]}

Zahn, Roland ^{[1
,13
,14
]}

Aislaitner, Georgios ^{[45
]}

Butlen-Ducuing, Florence ^{[46
]}

Fletcher, Christine ^{[47
]}

Haberkamp, Marion ^{[45
]}

Laughren, Thomas ^{[48
]}

Mantyla, Fanni-Laura ^{[49
]}

Schruers, Koen ^{[50
,51
]}

Thomson, Andrew ^{[52
]}

Arteaga-Henriquez, Gara ^{[53
,54
,55
]}

Benedetti, Francesco ^{[56
,57
]}

Cash-Gibson, Lucinda ^{[58
]}

Chae, Woo Ri ^{[59
]}

De Smedt, Heidi ^{[60
]}

Gold, Stefan M. ^{[59
,61
,62
]}

Hoogendijk, Witte J. G. ^{[63
]}

Mondragon, Valeria Jordan ^{[64
]}

Maron, Eduard ^{[65
,66
,67
,68
]}

Martynowicz, Jadwiga ^{[69
]}

机构：

[1] Kings Coll London, Inst Psychiat Psychol & Neurosci, Dept Psychol Med, London, England

[2] Univ Manchester, Fac Biol, Sch Biol Sci, Div Neurosci & Expt Psychol,Neurosci & Psychiat U, Manchester, Lancs, England

[3] Manchester Acad Hlth Sci Ctr, Manchester, Lancs, England

[4] Univ Bordeaux, Ctr Hosp Charles Perrens, Dept Gen & Acad Psychiat, Lab Nutr & Integrat Neurobiol UMR INRAE 1286, Bordeaux, France

[5] Univ Munster, Dept Psychiat & Psychotherapy, Munster, Germany

[6] Univ Munster, Otto Creutzfeldt Ctr Cognit & Behav Neurosci, Munster, Germany

[7] Tech Univ Dresden, Med Fac, Dept Psychiat & Psychotherapy, Univ Hosp Carl Gustav Carus, Dresden, Germany

[8] Univ Melbourne, Melbourne Med Sch, Dept Psychiat, Parkville, Vic, Australia

[9] Univ Melbourne, Florey Inst Neurosci & Mental Hlth, Parkville, Vic, Australia

[10] Royals Inst Mental Hlth Res, Mood Disorders Res Unit, Ottawa, ON, Canada

[11] Univ Ottawa, Dept Psychiat, Ottawa, ON, Canada

[12] Univ Ottawa, Dept Cellular & Mol Med, Ottawa, ON, Canada

[13] South London & Maudsley NHS Fdn Trust, Natl Inst Hlth Res, Mental Hlth Biomed Res Ctr, London, England

[14] Kings Coll London, London, England

[15] Univ Oxford, Dept Psychiat, Med Sci Div, Oxford, England

[16] APC Microbiome Ireland, Cork, Ireland

[17] Univ Coll Cork, Dept Psychiat & Neurobehav Sci, Cork, Ireland

[18] Univ Siena, Dept Mol Med, Div Psychiat, Siena, Italy

[19] Newcastle Univ, Translat & Clin Res Inst, Newcastle Upon Tyne, Tyne & Wear, England

[20] Goethe Univ, Depress Res Ctr, German Depress Fdn, Frankfurt, Germany

[21] Goethe Univ, Dept Psychiat Psychosomat & Psychotherapy, Frankfurt, Germany

[22] Univ Calif San Francisco, Dept Psychiat, San Francisco, CA USA

[23] Duke Univ, Dept Psychiat & Behav Sci, Sch Med, Durham, NC USA

[24] Univ Paris Est Creteil UPEC, Hop Univ Henri Mondor, AP HP,INSERM U955,IMRB,Translat Neuropsychiat Lab, Fdn FondaMental,Dept Medicouniv Addictol & Psychi, F-94010 Creteil, France

[25] Cumbria Northumberland Tyne & Wear NHS Fdn Trust, Newcastle Upon Tyne, Tyne & Wear, England

[26] Univ Toronto, Dept Psychiat, Toronto, ON, Canada

[27] Univ Toronto, Dept Pharmacol & Toxicol, Toronto, ON, Canada

[28] Univ Hlth Network, Mood Disorders Psychopharmacol Unit, Toronto, ON, Canada

[29] Brain & Cognit Discovery Fdn, Toronto, ON, Canada

[30] Heidelberg Univ, Med Fac Mannheim, Cent Inst Mental Hlth, Dept Psychiat & Psychotherapy, Sq J5, D-68159 Mannheim, Germany

[31] Emory Univ, Dept Psychiat & Behav Sci, Sch Med, Atlanta, GA 30322 USA

[32] Univ Texas Austin, Dept Psychiat, Dell Med Sch, Austin, TX 78712 USA

[33] Univ Freiburg, Med Ctr Univ Freiburg, Fac Med, Dept Psychiat & Psychotherapy, Hauptstr 5, D-79104 Freiburg, Germany

[34] Imperial Coll, Ctr Neuropsychopharmacol, Div Psychiat, London, England

[35] Univ Florence, Ist Neurosci, Florence, Italy

[36] Albert Einstein Coll Med, New York, NY USA

[37] Psychiat Univ Miami, Dept Psychiat & Behav Sci, Miami, FL USA

[38] Univ Modena, Dept Biomed Metab & Neural Sci, Modena, Italy

[39] VeraSci, Durham, NC USA

[40] Vrije Univ, Dept Psychiat, Amsterdam UMC, Amsterdam, Netherlands

[41] GGZinGeest, Amsterdam, Netherlands

[42] Stanford Univ, Dept Psychiat & Behav Sci, Stanford, CA 94305 USA

[43] Univ Alabama Birmingham, Dept Psychiat, Birmingham, AL USA

[44] Univ British Columbia, Dept Psychiat, Vancouver, BC, Canada

[45] BfArM, Fed Inst Drugs & Med Devices, Bundesinst Arzneimittel & Med Prod, Bonn, Germany

[46] European Med Agcy, Human Med Div, Off Therapies Neurol & Psychiat Disorders, Amsterdam, Netherlands

[47] GlaxoSmithKline, Biostat, London, England

[48] Laughren Psychopharm Consulting LLC, Rockville, MD USA

[49] GAMIAN Europe Global Alliance Mental Illness Advo, Brussels, Belgium

[50] Maastricht Univ, Sch Mental Hlth & Neurosci, Dept Psychiat & Psychol, EURON,Med Ctr, Maastricht, Netherlands

来源：

MOLECULAR PSYCHIATRY | 2022年 / 27卷 / 03期

基金：

欧盟地平线“2020”; 英国医学研究理事会;

关键词：

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

D O I：

10.1038/s41380-021-01381-x

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

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.

引用

页码：1286 / 1299

页数：14

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