Evidence map›Paper›PMID 34907394›Full record

ReviewMolecular psychiatry2022

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 and 51 more

Open access · hybridAbstract readConsensus StatementReview
In one paragraph

Review in Molecular psychiatry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 96 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 5 pooled it
21.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 5 syntheses or guidelines pooled it, 192 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2023
    Trial
  8. Review
  9. Treatment-resistant Depression in the Post-ketamine Era: Unmet Needs beyond Rapid Response.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2026
    Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Definition of treatment-resistant late-life depression: Conclusions from a European Task Force Delphi process.European psychiatry : the journal of the Association of European Psychiatrists · 2026
    Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Article

36 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

61 authors at 20 institutions in 13 countries.

Luca SforziniKing's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK. luca.sforzini@kcl.ac.uk.ORCID http://orcid.org/0000-0001-6795-0391
Courtney WorrellKing's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.ORCID http://orcid.org/0000-0003-0539-2376
Melisa KoseKing's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.
Ian M AndersonNeuroscience and Psychiatry Unit, Division of Neuroscience and Experimental Psychology, School of Biological Sciences, Faculty of Biological, Medical and Human Sciences, The University of Manchester and Manchester Academic Health Sciences Centre, Manchester, UK.
Bruno AouizerateDepartment of General and Academic Psychiatry, Centre Hospitalier Charles Perrens, Laboratory of Nutrition and Integrative Neurobiology (UMR INRAE 1286), University of Bordeaux, Bordeaux, France.
Volker AroltDepartment of Psychiatry and Psychotherapy, University of Münster, Münster, Germany.
Michael BauerDepartment of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Medical Faculty, Technische Universität Dresden, Dresden, Germany.ORCID http://orcid.org/0000-0002-2666-859X
Bernhard T BauneDepartment of Psychiatry and Psychotherapy, University of Münster, Münster, Germany.
Pierre BlierMood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.
Anthony J CleareKing's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.ORCID http://orcid.org/0000-0002-6990-939X
Philip J CowenMedical Sciences Division, Department of Psychiatry, University of Oxford, Oxford, UK.ORCID http://orcid.org/0000-0001-5518-6138
Timothy G DinanAPC Microbiome Ireland, Cork, Ireland; Department of Psychiatry and Neurobehavioral Sciences, University College Cork, Cork, Ireland.ORCID http://orcid.org/0000-0002-2316-7220
Andrea FagioliniDepartment of Molecular Medicine, Division of Psychiatry, University of Siena, Siena, Italy.
I Nicol FerrierTranslational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Ulrich HegerlDepression Research Center of the German Depression Foundation and Department of Psychiatry, Psychosomatics and Psychotherapy, Goethe University, Frankfurt, Germany.
Andrew D KrystalDepartment of Psychiatry, University of California, San Francisco, San Francisco, CA, USA.ORCID http://orcid.org/0000-0002-6702-781X
Marion LeboyerUniversité Paris Est Creteil (UPEC), AP-HP, Hôpitaux Universitaires Henri Mondor, Département Médico-Universitaire d'Addictologie et Psychiatrie (DMU IMPACT), INSERM U955, IMRB, translational Neuropsychiatry lab, Fondation FondaMental, F-94010, Creteil, France.ORCID http://orcid.org/0000-0001-5473-3697
R Hamish McAllister-WilliamsTranslational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.
Roger S McIntyreDepartment of Psychiatry, University of Toronto, Toronto, ON, Canada.
Andreas Meyer-LindenbergDepartment of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Square J5, 68159, Mannheim, Germany.
Andrew H MillerDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, 30322, USA.ORCID http://orcid.org/0000-0001-8260-7997
Charles B NemeroffDepartment of Psychiatry, University of Texas at Austin, Dell Medical School, Austin, TX, USA.ORCID http://orcid.org/0000-0001-7867-1160
Claus NormannDepartment for Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstrasse 5, 79104, Freiburg, Germany.ORCID http://orcid.org/0000-0001-5693-8936
David NuttCentre for Neuropsychopharmacology, Division of Psychiatry, Imperial College, London, London, UK.ORCID http://orcid.org/0000-0002-1286-1401
Stefano PallantiIstituto di Neuroscience, University of Florence, Italy; Albert Einstein College of Medicine, New York, USA.
Luca PaniDepartment of Psychiatry and Behavioral Sciences, Psychiatry University of Miami, Miami, FL, USA.
Brenda W J H PenninxDepartment of Psychiatry, Amsterdam UMC, Vrije Universiteit and GGZinGeest, Amsterdam, the Netherlands.
Alan F SchatzbergDepartment of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
Richard C SheltonDepartment of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.
Lakshmi N YathamDepartment of Psychiatry, University of British Columbia, Vancouver, British Columbia, Canada.
Allan H YoungKing's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.ORCID http://orcid.org/0000-0003-2291-6952
Roland ZahnKing's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.
Georgios AislaitnerFederal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Bonn, Germany.
Florence Butlen-DucuingOffice of Therapies for Neurological and Psychiatric disorders, Human Medicines Division, European Medicines Agency, Amsterdam, the Netherlands.
Christine FletcherBiostatistics, GlaxoSmithKline, London, UK.
Marion HaberkampFederal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Bonn, Germany.
Thomas LaughrenLaughren Psychopharm Consulting, LLC, Rockville, MD, USA.
Fanni-Laura MäntyläGAMIAN-Europe (Global Alliance of Mental Illness Advocacy Networks-Europe), Brussels, Belgium.
Koen SchruersDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.
Andrew ThomsonData, Analytics and Methodology Taskforce, European Medicines Agency, Amsterdam, the Netherlands.
Gara Arteaga-HenríquezDepartment of Psychiatry, Hospital Universitari Vall d'Hebron (HUVH), Barcelona, Catalonia, Spain.
Francesco BenedettiVita-Salute San Raffaele University, Milan, Italy.ORCID http://orcid.org/0000-0003-4949-856X
Lucinda Cash-GibsonStrategic Projects Unit, Vall d 'Hebron Research Institute (VHIR), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Woo Ri ChaeCharité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Berlin, Germany.ORCID http://orcid.org/0000-0002-6326-8333
Heidi De SmedtJanssen Research & Development, Beerse, Belgium.
Stefan M GoldCharité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Berlin, Germany.ORCID http://orcid.org/0000-0001-5188-4799
Witte J G HoogendijkDepartment of Psychiatry, Erasmus University Medical Centre, Rotterdam, the Netherlands.
Valeria Jordán MondragónMedical Director Neuroscience for Region Europe at Novartis Pharma, Basel, Switzerland.
Eduard MaronDepartment of Psychiatry, University of Tartu, Tartu, Estonia.
Jadwiga MartynowiczDepartment of Global Regulatory Affairs, Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.
Elisa MelloniVita-Salute San Raffaele University, Milan, Italy.
Christian OtteCharité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Berlin, Germany.ORCID http://orcid.org/0000-0002-4051-997X
Gabriela Perez-FuentesGroup of Psychiatry, Mental Health and Addictions, Vall d'Hebron Research Institute (VHIR), Barcelona, Catalonia, Spain.
Sara PolettiDivision of Neuroscience, Psychiatry and Clinical Psychobiology, IRCCS Scientific Institute Ospedale San Raffaele, Milan, Italy.ORCID http://orcid.org/0000-0001-9594-0246
Mark E SchmidtExperimental Medicine, Janssen Research & Development, Janssen Pharmaceutica NV, Beerse, Belgium.
Edwin van de KetterijEuropean Infrastructure for Translational Medicine (EATRIS), Amsterdam, Netherlands.ORCID http://orcid.org/0000-0001-5332-3549
Katherine WooDepartment of Global Regulatory Affairs, Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.
Yanina FlossbachNeuroscience, Global Drug Development, Novartis Pharma AG, Basel, Switzerland.
J Antoni Ramos-QuirogaDepartment of Psychiatry, Hospital Universitari Vall d'Hebron (HUVH), Barcelona, Catalonia, Spain.ORCID http://orcid.org/0000-0003-1622-0350
Adam J SavitzDepartment of Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.
Carmine M ParianteKing's College London, Institute of Psychiatry, Psychology and Neuroscience, Department of Psychological Medicine, London, UK.ORCID http://orcid.org/0000-0002-9132-5091
King's College London · GBJanssen (United States) · USUniversitat Autònoma de Barcelona · ESCharité - Universitätsmedizin Berlin · DEEuropean Medicines Agency · NLFederal Institute for Drugs and Medical Devices · DEJanssen (Belgium) · BENovartis (Switzerland) · CHVita-Salute San Raffaele University · ITAlbert Einstein College of Medicine · USCumbria Northumberland Tyne and Wear NHS Foundation Trust · GBDuke University · USEast Tallinn Central Hospital · EEEmory University · USErasmus University Rotterdam · NLGGZ inGeest · NLGlaxoSmithKline (United Kingdom) · GBGlobal Alliance of Mental Illness Advocacy Networks-Europe · BEGoethe University Frankfurt · DEHeidelberg University · DE

Funding

Medical Research Council G108/603Medical Research Council MR/S003037/1
6 · The paper itself

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.

Indexed as

Depressive Disorder, Treatment-ResistantMajor Depressive DisorderAdaptive Clinical Trials as TopicDepressionHumans

Identifiers

PMID34907394
PMCPMC9095475
OpenAlexW4200627112

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.