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Record W4200627112 · doi:10.1038/s41380-021-01381-x

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

2021· review· en· W4200627112 on OpenAlex
Luca Sforzini, Courtney Worrell, Melisa Kose, Ian 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, Jadwiga Martynowicz, Elisa Melloni, Christian Otte, Gabriela Pérez-Fuentes, Sara Poletti, Mark E. Schmidt, Edwin van de Ketterij, Katherine Woo, Yanina Flossbach, Josep Antoni Ramos‐Quiroga, Adam Savitz, Carmine M. Pariante

Why this work is in the frame

A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.

affAt least one author lists a Canadian institution in the pinned OpenAlex snapshot.
fundA Canadian funder is recorded on the work.

Bibliographic record

VenueMolecular Psychiatry · 2021
Typereview
Languageen
FieldMedicine
TopicTreatment of Major Depression
Canadian institutionsUniversity of British ColumbiaUniversity Health NetworkUniversity of TorontoBrain and Cognition Discovery FoundationRoyal Ottawa Mental Health CentreUniversity of Ottawa
FundersJanssen PharmaceuticalsNational Institute of Mental HealthAllerganMedical Research CouncilNeuraxpharmSunovionH. Lundbeck A/SDaiichi Sankyo EuropeServierDeutsche ForschungsgemeinschaftBundesministerium für Bildung und ForschungNational Institute for Health and Care ResearchNational Institutes of HealthMylanPfizerLivaNovaCilagItalfarmacoWellcome TrustPurdue UniversityEuropean CommissionSpringworks TherapeuticsFondation FondaMentalInnovative Medicines InitiativeEuropean Federation of Pharmaceutical Industries and AssociationsAgency for Healthcare Research and QualityCanadian Institutes of Health ResearchDaimler und Benz StiftungSanofiBristol-Myers Squibb
KeywordsClinical trialDelphi methodProtocol (science)Major depressive disorderDelphiTreatment-resistant depressionDepression (economics)GuidelineMedicinePsychologyAlternative medicinePsychiatryCognitionComputer sciencePathology

Abstract

fetched live from OpenAlex

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.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.004
metaresearch head score (Gemma)0.005
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Other design · Consensus signal: none
GenreCandidate signal: Review · Consensus signal: Review
Teacher disagreement score0.940
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0040.005
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0070.007
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0010.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.334
GPT teacher head0.558
Teacher spread0.224 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it