TY - JOUR
T1 - Absolute neutrophil count and adverse drug reaction monitoring during clozapine treatment
T2 - consensus guidelines from a global Delphi panel
AU - Siskind, Dan
AU - Northwood, Korinne
AU - Pillinger, Toby
AU - Chan, Sherry
AU - Correll, Christoph U.
AU - Cotes, Robert O.
AU - Every-Palmer, Susanna
AU - Hahn, Margaret
AU - Howes, Oliver
AU - Kane, John M.
AU - Kelly, Deanna
AU - Korman, Nicole
AU - Lappin, Julia
AU - Mena, Cristián
AU - Myles, Nicholas
AU - McCutcheon, Robert A.
AU - Siskind, Dan
AU - McCutcheon, Robert A.
AU - Northwood, Korinne
AU - Pillinger, Toby
AU - Chan, Sherry
AU - Correll, Christoph U.
AU - Cotes, Robert
AU - Every-Palmer, Susanna
AU - Hahn, Margaret
AU - Howes, Oliver
AU - Kane, John M.
AU - Kelly, Deanna L.
AU - Korman, Nicole
AU - Lappin, Julia
AU - Mena, Cristián
AU - Myles, Nicholas
AU - Agid, Ofer
AU - Arango, Celso
AU - Asmal, Laila
AU - Ayinde, Olatunde O.
AU - Baptiste, Trino
AU - Béchard, Laurent
AU - Bitter, Istvan
AU - Bittner, Robert A.
AU - Breznoscakova, Dagmar
AU - Chen, Eric
AU - Chkonia, Eka
AU - Citrome, Leslie
AU - Clark, Scott R.
AU - Corbeil, Olivier
AU - Cordoba, Rodrigo
AU - Crossley, Nicolas
AU - de Bartolomeis, Andrea
AU - Ebdrup, Bjørn H.
AU - Fernandez-Egea, Emilio
AU - Elkis, Helio
AU - Eltorki, Yassin
AU - Šimunović Filipčić, Ivona
AU - de Filippis, Renato
AU - Fleischhacker, Wolfgang
AU - Freudenreich, Oliver
AU - Gadelha, Ary
AU - Gama, Clarissa S.
AU - Gaughran, Fiona
AU - Gee, Siobhan
AU - Guinart, Daniel
AU - Hallak, Jaime Eduardo Cecilio
AU - Harris, Anthony
AU - Hasan, Alkomiet
AU - Honer, William
AU - Jayaram, Mahesh
AU - Kanazawa, Tetsufumi
AU - Kawashima, Hirotsugu
AU - Keating, Dolores
AU - Kim, Se Hyun
AU - Kwon, Jun Soo
AU - Lane, Hsien Yuan
AU - Lee, Jimmy
AU - Lennox, Belinda
AU - de Leon, Jose
AU - Leung, Jonathan G.
AU - Luykx, Jurjen J.
AU - MacCabe, James
AU - Murray, Graham
AU - Nielsen, Jimmi
AU - O'Donoghue, Brian
AU - Oloyede, Ebenezer
AU - Qubad, Mishal
AU - Remington, Gary
AU - Roy, Marc André
AU - Rubio, Jose
AU - Sagud, Marina
AU - Schulte, Peter F.J.
AU - Selten, Jean Paul
AU - Si, Tianmei
AU - Smith, Lesley
AU - Sommer, Iris
AU - Sundram, Suresh
AU - Taipale, Heidi
AU - Takeuchi, Hiroyoshi
AU - Tandon, Rajiv
AU - Tanzer, Timothy
AU - Taylor, David
AU - Thirthalli, Jagadisha
AU - Tiihonen, Jari
AU - Uchida, Hiroyuki
AU - Venkatasubramanian, Ganesan
AU - Verdoux, Hélène
AU - Wagner, Elias
AU - Xin, Yu
AU - Yağcıoğlu, A. Elif Anıl
AU - Yung, Alison
AU - the Clozapine Delphi Expert Panel
N1 - Publisher Copyright:
© 2025 Elsevier Ltd
PY - 2026/1
Y1 - 2026/1
N2 - Despite its superior effectiveness for treatment-resistant schizophrenia, clozapine has a high burden of adverse drug reactions (ADRs), which require monitoring and treatment. This global Delphi study has established consensus guidelines for absolute neutrophil count (ANC) thresholds for consideration of clozapine cessation and provided monitoring protocols for ADR management. Recommendations include lowering ANC cessation thresholds to 1·0 × 109 cells per L (0·5 × 109 cells per L for Duffy antigen receptor for chemokines-null individuals) and discontinuing routine ANC monitoring after 2 years. Comprehensive ADR monitoring every 3 months should address the metabolic syndrome, constipation, gastro-oesophageal reflux, sialorrhea, nocturnal enuresis, tachycardia, sleep apnoea, sedation, and other ADRs. Consumer representatives underscored the need for shared decision-making, streamlined monitoring, and accessible patient education. Although barriers persist, these findings support updating global policies to reduce burden on patients, enhance adherence, and optimise clinical outcomes. Incorporating evidence-based guidelines into practice could transform clozapine care, balancing safety with practicality to improve the lives of those with treatment-resistant schizophrenia.
AB - Despite its superior effectiveness for treatment-resistant schizophrenia, clozapine has a high burden of adverse drug reactions (ADRs), which require monitoring and treatment. This global Delphi study has established consensus guidelines for absolute neutrophil count (ANC) thresholds for consideration of clozapine cessation and provided monitoring protocols for ADR management. Recommendations include lowering ANC cessation thresholds to 1·0 × 109 cells per L (0·5 × 109 cells per L for Duffy antigen receptor for chemokines-null individuals) and discontinuing routine ANC monitoring after 2 years. Comprehensive ADR monitoring every 3 months should address the metabolic syndrome, constipation, gastro-oesophageal reflux, sialorrhea, nocturnal enuresis, tachycardia, sleep apnoea, sedation, and other ADRs. Consumer representatives underscored the need for shared decision-making, streamlined monitoring, and accessible patient education. Although barriers persist, these findings support updating global policies to reduce burden on patients, enhance adherence, and optimise clinical outcomes. Incorporating evidence-based guidelines into practice could transform clozapine care, balancing safety with practicality to improve the lives of those with treatment-resistant schizophrenia.
UR - https://www.scopus.com/pages/publications/105009898777
U2 - 10.1016/S2215-0366(25)00098-7
DO - 10.1016/S2215-0366(25)00098-7
M3 - Review Article
AN - SCOPUS:105009898777
SN - 2215-0366
VL - 13
SP - 77
EP - 86
JO - The Lancet Psychiatry
JF - The Lancet Psychiatry
IS - 1
ER -