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Record W4200576566 · doi:10.1055/a-1625-6388

An International Adult Guideline for Making Clozapine Titration Safer by Using Six Ancestry-Based Personalized Dosing Titrations, CRP, and Clozapine Levels

2021· article· en· W4200576566 on OpenAlexaff
José de León, Georgios Schoretsanitis, Robert L. Smith, Espen Molden, Anssi Solismaa, Niko Seppälä, Miloslav Kopeček, Patrik Švancer, I. Cánovas Olmos, Carina Ricciardi, Celso Iglesias García, Ana Iglesias-Alonso, Edoardo Spina, Can‐Jun Ruan, Chuanyue Wang, Gang Wang, Yi‐lang Tang, Shih‐Ku Lin, Hsien‐Yuan Lane, Yong Sik Kim, Se Hyun Kim, Anto P. Rajkumar, Dinora F. González‐Esquivel, Helgi Jung–Cook, Trino Baptista, Christopher Rohde, Jimmi Nielsen, Hélène Verdoux, Clélia Quilès, Emílio J. Sanz, Carlos De las Cuevas, Dan Cohen, Peter F.J. Schulte, Aygün Ertuğrul, A. Elif Anıl Yağcıoğlu, Nitin Chopra, Betsy McCollum, Charles Shelton, Robert O. Cotes, Arun R. Kaithi, John M. Kane, Saeed Farooq, Chee H. Ng, John Bilbily, Christoph Hiemke, Carlos López‐Jaramillo, Ian R. McGrane, Fernando Lana, Chin B. Eap, Manuel Arrojo, Flavian Ștefan Rădulescu, Erich Seifritz, Susanna Every‐Palmer, Chad Bousman, Emmanuel Bebawi, Rahul Bhattacharya, Deanna L. Kelly, Yuji Otsuka, Judit Lazáry, Rafael Torres, Agustín Yécora, Mariano Motuca, Sherry Kit Wa Chan, Monica Zolezzi, Sami Ouanes, Domenico De Berardis, Sandeep Grover, Ric M. Procyshyn, Richard A. Adebayo, О.О. Кирилочев, A. G. Soloviev, Konstantinos Ν. Fountoulakis, Alina Wilkowska, Wiesław Jerzy Cubała, Muhammad Ayub, Alzira Silva, Raphael M. Bonelli, José María Villagrán Moreno, Benedicto Crespo‐Facorro, Henk Temmingh, Eric Decloedt, Maria Rosel Pedro, Hiroyoshi Takeuchi, Masaru Tsukahara, Gerhard Gründer, Marina Šagud, Andreja Čelofiga, Dragana Ignjatović Ristić, Bruno Bertolucci Ortiz, Hélio Elkis, António Pacheco Palha, Adrián LLerena, Emilio Fernández-Egea, Dan Siskind, Abraham Weizman, R. Masmoudi, Shamin Mohd Saffian, Jonathan G. Leung, P.F. Buckley, Stephen R. Marder, Leslie Citrome, Oliver Freudenreich, Christoph U. Correll, Daniel J. Müller

Bibliographic record

VenuePharmacopsychiatry · 2021
Typearticle
Languageen
FieldMedicine
TopicSchizophrenia research and treatment
Canadian institutionsSchizophrenia Society of OntarioQueen's UniversityBC Mental Health & Substance Use ServicesUniversity of British ColumbiaUniversité de MontréalHôpital du Sacré-Cœur de MontréalUniversity of CalgaryUniversity of TorontoCentre for Addiction and Mental Health
FundersLundbeckfondenUniversity of Kentucky
KeywordsMedicineClozapinePopulationDosingPharmacokineticsGuidelineAdverse effectPharmacologyInternal medicinePsychiatrySchizophrenia (object-oriented programming)Environmental healthPathology

Abstract

fetched live from OpenAlex

This international guideline proposes improving clozapine package inserts worldwide by using ancestry-based dosing and titration. Adverse drug reaction (ADR) databases suggest that clozapine is the third most toxic drug in the United States (US), and it produces four times higher worldwide pneumonia mortality than that by agranulocytosis or myocarditis. For trough steady-state clozapine serum concentrations, the therapeutic reference range is narrow, from 350 to 600 ng/mL with the potential for toxicity and ADRs as concentrations increase. Clozapine is mainly metabolized by CYP1A2 (female non-smokers, the lowest dose; male smokers, the highest dose). Poor metabolizer status through phenotypic conversion is associated with co-prescription of inhibitors (including oral contraceptives and valproate), obesity, or inflammation with C-reactive protein (CRP) elevations. The Asian population (Pakistan to Japan) or the Americas' original inhabitants have lower CYP1A2 activity and require lower clozapine doses to reach concentrations of 350 ng/mL. In the US, daily doses of 300-600 mg/day are recommended. Slow personalized titration may prevent early ADRs (including syncope, myocarditis, and pneumonia). This guideline defines six personalized titration schedules for inpatients: 1) ancestry from Asia or the original people from the Americas with lower metabolism (obesity or valproate) needing minimum therapeutic dosages of 75-150 mg/day, 2) ancestry from Asia or the original people from the Americas with average metabolism needing 175-300 mg/day, 3) European/Western Asian ancestry with lower metabolism (obesity or valproate) needing 100-200 mg/day, 4) European/Western Asian ancestry with average metabolism needing 250-400 mg/day, 5) in the US with ancestries other than from Asia or the original people from the Americas with lower clozapine metabolism (obesity or valproate) needing 150-300 mg/day, and 6) in the US with ancestries other than from Asia or the original people from the Americas with average clozapine metabolism needing 300-600 mg/day. Baseline and weekly CRP monitoring for at least four weeks is required to identify any inflammation, including inflammation secondary to clozapine rapid titration.

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.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.005
metaresearch head score (Gemma)0.014
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Methods · Consensus signal: none
Teacher disagreement score0.021
Threshold uncertainty score0.042

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0050.014
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0010.003
Bibliometrics0.0020.002
Science and technology studies0.0010.001
Scholarly communication0.0020.001
Open science0.0030.001
Research integrity0.0050.004
Insufficient payload (model declined to judge)0.0110.009

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 head0.077
GPT teacher head0.436
Teacher spread0.359 · 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

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNot applicable
Domainnot available
GenreMethods

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations259
Published2021
Admission routes1
Has abstractyes

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