{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T14:14:00Z","timestamp":1783606440138,"version":"3.55.0"},"reference-count":20,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Psychopharmacology"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Amisulpride is an important antipsychotic used in the treatment of schizophrenia, yet its exposure shows inter-individual variability. Although therapeutic drug monitoring (TDM) is recommended, supratherapeutic concentrations (&gt;600\u2009ng\/mL) still occur in routine practice and may increase the risk of adverse effects. However, practical risk prediction studies of supratherapeutic amisulpride exposure based on routine clinical variables remain limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>To identify patients at increased risk of supratherapeutic amisulpride exposure in routine psychiatric care and to develop a clinically interpretable risk prediction approach based on routinely available clinical variables.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>This was a retrospective observational study using real-world TDM data from psychiatric inpatients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Therapeutic drug monitoring data were retrospectively analyzed. Patients were split at the patient level into training (70%) and validation (30%) cohorts. To identify the optimal representation of renal function and drug elimination, predictors were organized into three candidate pools: (i) apparent clearance (CL\/F) calculated from the final covariate equation of a previously published population pharmacokinetic model, (ii) estimated creatinine clearance (eCLcr), and (iii) the original clinical variables used to calculate eCLcr. Within each candidate predictor pool, predictors were screened using LASSO-penalized logistic regression and then entered into multivariable logistic regression. The most clinically practical model was selected for nomogram construction. Model performance was assessed by discrimination, calibration, and decision curve analysis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>A total of 413 steady-state trough samples from 299 patients were analyzed, of which 19.6% exceeded a steady-state trough plasma concentration of 600\u2009ng\/mL. Reduced renal function and higher daily doses were consistently associated with an increased risk of supratherapeutic exposure. Among the three candidate strategies, the Key Covariate-based strategy achieved acceptable discrimination in both the training (area under the receiver operating characteristic curve (AUC) 0.738) and validation (AUC 0.720) cohorts, with good calibration. Decision curve analysis suggested potential clinical utility across a range of lower to moderate threshold probabilities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>A simple risk stratification approach based on eCLcr and daily dose may offer a reference for individualized risk assessment. This model may provide preliminary support for identifying patients at risk of supratherapeutic exposure in routine psychiatric practice.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20451253261460142","type":"journal-article","created":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T08:59:05Z","timestamp":1783414745000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Identifying patients at risk of supratherapeutic amisulpride exposure in routine psychiatric practice: a real-world therapeutic drug monitoring study"],"prefix":"10.1177","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-7092-8338","authenticated-orcid":false,"given":"Keyu","family":"Yan","sequence":"first","affiliation":[{"name":"Department of Pharmacy, Xi\u2019an Mental Health Center, Xi\u2019an, Shaanxi, P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0721-5296","authenticated-orcid":false,"given":"Gehang","family":"Ju","sequence":"additional","affiliation":[{"name":"Institute of Big Data, Central South University, Changsha, Hunan, P.R. China"},{"name":"Hunan University of Medicine General Hospital, Changsha, Hunan, P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aowei","family":"Li","sequence":"additional","affiliation":[{"name":"Institute of Public Health, Tianjin University of Traditional Chinese Medicine, Tianjin, P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruomei","family":"Gao","sequence":"additional","affiliation":[{"name":"Biomedical Big Data Center, West China Hospital of Sichuan University, Chengdu, Sichuan, P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Na","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Xi\u2019an Mental Health Center, Xi\u2019an, Shaanxi, P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-4052-5317","authenticated-orcid":false,"given":"Qing","family":"Shao","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Xi\u2019an Mental Health Center, No. 666, Kanghe Road, Chang\u2019an District, Xi\u2019an, Shaanxi, 710100, P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,7,7]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sby058"},{"key":"e_1_3_4_3_2","unstructured":"Center for Drug Evaluation and Research. Risk assessment and risk mitigation review(s) for NDA 209510Orig1s000: Barhemsys (amisulpride). Silver Spring MD: U.S. Food and Drug Administration; 2020. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2020\/209510Orig1s000RiskR.pdf (accessed 28 April 2026)."},{"key":"e_1_3_4_4_2","article-title":"Amisulpride: a useful second-generation antipsychotic omitted from the US residency training curriculum","volume":"23","author":"Gupta M","year":"2021","unstructured":"Gupta M. Amisulpride: a useful second-generation antipsychotic omitted from the US residency training curriculum. Prim Care Companion CNS Disord 2021; 23: 20br02903.","journal-title":"Prim Care Companion CNS Disord"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.3109\/15622975.2012.696143"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.2174\/1872312813666191018152226"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.5414\/CP203000"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-200746050-00001"},{"key":"e_1_3_4_9_2","article-title":"Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: update 2017","volume":"51","author":"Hiemke C","year":"2018","unstructured":"Hiemke C, Bergemann N, Clement HW, et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: update 2017. Pharmacopsychiatry 2018; 51: e1.","journal-title":"Pharmacopsychiatry"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0447.2009.01429.x"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S469149"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajp.2023.103699"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.5414\/cp204334"},{"key":"e_1_3_4_14_2","first-page":"31","article-title":"Discussion on the reference range and alert level of amisulpride in the treatment of schizophrenia","volume":"35","author":"Zhang Y","year":"2022","unstructured":"Zhang Y, Sun L, Li C, et al. Discussion on the reference range and alert level of amisulpride in the treatment of schizophrenia. Sichuan Mental Health 2022; 35: 31\u201336.","journal-title":"Sichuan Mental Health"},{"key":"e_1_3_4_15_2","first-page":"601","article-title":"Expert consensus on clinical application of psychiatric therapeutic drug monitoring in China (2022 edition) (in Chinese)","volume":"22","author":"Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society","year":"2022","unstructured":"Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society. Expert consensus on clinical application of psychiatric therapeutic drug monitoring in China (2022 edition) (in Chinese). J Neurosci Mental Health 2022; 22: 601\u2013608.","journal-title":"J Neurosci Mental Health"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1159\/000180580"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-150-9-200905050-00006"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.39335.541782.AD"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1002\/hup.2256"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1177\/20451253221136754"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.heliyon.2023.e21866"}],"container-title":["Therapeutic Advances in Psychopharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20451253261460142","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/20451253261460142","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/20451253261460142","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T13:19:04Z","timestamp":1783603144000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/20451253261460142"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":20,"alternative-id":["10.1177\/20451253261460142"],"URL":"https:\/\/doi.org\/10.1177\/20451253261460142","relation":{},"ISSN":["2045-1253","2045-1261"],"issn-type":[{"value":"2045-1253","type":"print"},{"value":"2045-1261","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7]]},"article-number":"20451253261460142"}}