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15. Exploring low clozapine C/D ratios, inverted clozapine-norclozapine ratios and undetectable concentrations as measures of non-adherence in clozapine patients: A literature review and a case series of 17 patients from 3 studies

Author

Ruan, Can-Jun, Olmos, Ismael, Ricciardi, Carina, Schoretsanitis, Georgios, Vincent, Philippe D., Anıl Yağcıoğlu, A. Elif, Eap, Chin B., Baptista, Trino, Clark, Scott R., Fernandez-Egea, Emilio, Kim, Se Hyun, Lane, Hsien-Yuan, Leung, Jonathan, Maroñas Amigo, Olalla, Motuca, Mariano, Every-Palmer, Susanna, Procyshyn, Ric M., Rohde, Christopher, Suhas, Satish, Schulte, Peter F.J., Spina, Edoardo, Takeuchi, Hiroyoshi, Verdoux, Hélène, Correll, Christoph U., Molden, Espen, De Las Cuevas, Carlos, and de Leon, Jose

Published
2024
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16. Clozapine ultrarapid metabolism during weak induction probably exists but requires careful diagnosis. A literature review, five new cases and a proposed definition

Author

Schoretsanitis, Georgios, Anıl Yağcıoğlu, A. Elif, Ruan, Can-Jun, Eap, Chin B., Molden, Espen, Baptista, Trino, Clark, Scott R., Fernandez-Egea, Emilio, Kim, Se Hyun, Lane, Hsien-Yuan, Leung, Jonathan, Maroñas Amigo, Olalla, Motuca, Mariano, Olmos, Ismael, Every-Palmer, Susanna, Procyshyn, Ric M., Rohde, Christopher, Satish, Suhas, Schulte, Peter F.J., Spina, Edoardo, Takeuchi, Hiroyoshi, Verdoux, Hélène, Correll, Christoph U., and de Leon, Jose

Published
2024
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25. Guía internacional para una dosificación más segura de la clozapina en adultos mediante el uso de 6 titulaciones personalizadas de dosis basados en la etnicidad, la proteína C reactiva y los niveles de clozapina

Author

de Leon, Jose, Schoretsanitis, Georgios, Smith, Robert L., Molden, Espen, Solismaa, Anssi, Seppälä, Niko, Kopeček, Miloslav, Švancer, Patrik, Olmos, Ismael, Ricciardi, Carina, Iglesias-Garcia, Celso, Iglesias-Alonso, Ana, Spina, Edoardo, Ruan, Can-Jun, Wang, Chuan-Yue, Wang, Gang, Tang, Yi-Lang, Lin, Shih-Ku, Lane, Hsien-Yuan, Kim, Yong Sik, Kim, Se Hyun, Rajkumar, Anto P., González-Esquivel, Dinora F., Jung-Cook, Helgi, Baptista, Trino, Rohde, Christopher, Nielsen, Jimmi, Verdoux, Hélène, Quiles, Clelia, Sanz, Emilio J., De las Cuevas, Carlos, Cohen, Dan, Schulte, Peter F.J., Ertuğrul, Aygün, Anıl Yağcıoğlu, A. Elif, Chopra, Nitin, McCollum, Betsy, Shelton, Charles, Cotes, Robert O., Kaithi, Arun R., Kane, John M., Farooq, Saeed, Ng, Chee H., Bilbily, John, Hiemke, Christoph, López-Jaramillo, Carlos, McGrane, Ian, Lana, Fernando, Eap, Chin B., Arrojo-Romero, Manuel, Rădulescu, Flavian Ştefan, Seifritz, Erich, Every-Palmer, Susanna, Bousman, Chad A., Bebawi, Emmanuel, Bhattacharya, Rahul, Kelly, Deanna L., Otsuka, Yuji, Lazary, Judit, Torres, Rafael, Yecora, Agustin, Motuca, Mariano, Chan, Sherry Kit Wa, Zolezzi, Monica, Ouanes, Sami, De Berardis, Domenico, Grover, Sandeep, Procyshyn, Ric M., Adebayo, Richard A., Kirilochev, Oleg O., Soloviev, Andrey, Fountoulakis, Konstantinos N., Wilkowska, Alina, Cubała, Wiesław Jerzy, Ayub, Muhammad, Silva, Alzira, Bonelli, Raphael M., Villagrán-Moreno, José María, Crespo-Facorro, Benedicto, Temmingh, Henk, Decloedt, Eric, Pedro, Maria Rosel, Takeuchi, Hiroyoshi, Tsukahara, Masaru, Gründer, Gerhard, Sagud, Marina, Celofiga, Andreja, Ignjatovic Ristic, Dragana, Ortiz, Bruno Bertolucci, Elkis, Helio, Pacheco Palha, António José, Llerena, Adrián, Fernandez-Egea, Emilio, Siskind, Dan, Weizman, Abraham, Masmoudi, Rim, Mohd Saffian, Shamin, Leung, Jonathan G., Buckley, Peter F., Marder, Stephen R., Citrome, Leslie, Freudenreich, Oliver, Correll, Christoph U., and Müller, Daniel J.

Published
2023
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37. Postpartum hemorrhage and postpartum depression: A systematic review and meta‐analysis of observational studies.

Author

Schoretsanitis, Georgios, Gastaldon, Chiara, Ochsenbein‐Koelble, Nicole, Olbrich, Sebastian, Barbui, Corrado, and Seifritz, Erich

Subjects
*MENTAL illness, *POSTPARTUM depression, *POSTPARTUM hemorrhage, *BODY mass index, *AFFECTIVE disorders
Abstract

Objective: To assess the postpartum depression (PPD) risk in women with postpartum hemorrhage (PPH) and moderators. Methods: We identified observational studies of PPD rates in women with versus without PPH in Embase/Medline/PsychInfo/Cinhail in 09/2022. Study quality was evaluated using the Newcastle‐Ottawa‐Scale. Our primary outcome was the odds ratio (OR, 95% confidence intervals [95%CI]) of PPD in women with versus without PPH. Meta‐regression analyses included the effects of age, body mass index, marital status, education, history of depression/anxiety, preeclampsia, antenatal anemia and C‐section; subgroup analyses were based on PPH and PPD assessment methods, samples with versus without history of depression/anxiety, from low‐/middle‐ versus high‐income countries. We performed sensitivity analyses after excluding poor‐quality studies, cross‐sectional studies and sequentially each study. Results: One, five and three studies were rated as good‐, fair‐ and poor‐quality respectively. In nine studies (k = 10 cohorts, n = 934,432), women with PPH were at increased PPD risk compared to women without PPH (OR = 1.28, 95% CI = 1.13 to 1.44, p < 0.001), with substantial heterogeneity (I2 = 98.9%). Higher PPH‐related PPD ORs were estimated in samples with versus without history of depression/anxiety or antidepressant exposure (OR = 1.37, 95%CI = 1.18 to 1.60, k = 6, n = 55,212, versus 1.06, 95%CI = 1.04 to 1.09, k = 3, n = 879,220, p < 0.001) and in cohorts from low‐/middle‐ versus high‐income countries (OR = 1.49, 95%CI = 1.37 to 1.61, k = 4, n = 9197, versus 1.13, 95%CI = 1.04 to 1.23, k = 6, n = 925,235, p < 0.001). After excluding low‐quality studies the PPD OR dropped (1.14, 95%CI = 1.02 to 1.29, k = 6, n = 929,671, p = 0.02). Conclusions: Women with PPH had increased PPD risk amplified by history of depression/anxiety, whereas more data from low‐/middle‐income countries are required. [ABSTRACT FROM AUTHOR]

Published
2024
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38. Discovering interactions in polypharmacy: Impact of metamizole on the metabolism of quetiapine.

Author

Watermeyer, Fabian, Gaebler, Arnim Johannes, Neuner, Irene, Haen, Ekkehard, Hiemke, Christoph, Schoretsanitis, Georgios, and Paulzen, Michael

Subjects
DRUG side effects, DRUG monitoring, DRUG interactions, CYTOCHROME P-450, TREATMENT failure
Abstract

Aims: Metamizole is quite an old drug with analgesic, antipyretic and spasmolytic properties. Recent findings have shown that it may induce several cytochrome P450 (CYP) enzymes, especially CYP3A4 and CYP2B6. The clinical relevance of these properties is uncertain. We aimed to unravel potential pharmacokinetic interactions between metamizole and the CYP3A4 substrate quetiapine. Methods: Plasma concentrations of quetiapine from a large therapeutic drug monitoring database were analysed. Two groups of 33 patients, either receiving quetiapine as a monotherapy (without CYP modulating comedications) or with concomitantly applied metamizole, were compared addressing a potential impact of metamizole on the metabolism of quetiapine being reflected in differences of plasma concentrations of quetiapine and dose‐adjusted plasma concentrations. Results: Patients comedicated with metamizole showed >50% lower plasma concentrations of quetiapine (median 45.2 ng/mL, Q1 = 15.5; Q3 = 90.5 vs. 92.0 ng/mL, Q1 = 52.3; Q3 = 203.8, P =.003). The dose‐adjusted plasma concentrations were 69% lower in the comedication group (P =.001). Subgroup analyses did not suggest a dose dependency of the metamizole effect or an influence of quetiapine formulation (immediate vs. extended release). Finally, the comedication group exhibited a significantly higher proportion of patients whose quetiapine concentrations were below the therapeutic reference range (78.8% in the metamizole group vs. 54.4% in the control group, P =.037) indicating therapeutically insufficient drug concentrations. Conclusion: The combination of metamizole and quetiapine leads to significantly lower drug concentrations of quetiapine, probably via an induction of CYP3A4. Clinicians must consider the risk of adverse drug reactions, especially treatment failure under quetiapine when adding metamizole. [ABSTRACT FROM AUTHOR]

Published
2024
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39. Pharmacokinetic interaction of quetiapine and lamotrigine – victim and perpetrator?

Author

Gilleßen, Florian, Gaebler, Arnim Johannes, Haen, Ekkehard, Schoretsanitis, Georgios, Wozniak, Justyna, Stingl, Julia C., and Paulzen, Michael

Subjects
DRUG monitoring, DRUG interactions, LAMOTRIGINE, GLUCURONOSYLTRANSFERASE, QUETIAPINE
Abstract

Objective: We aimed to investigate the ambiguous findings of earlier research regarding the reduction of quetiapine plasma levels when combined with lamotrigine, most likely via UDP-glucuronosyltransferase induction by lamotrigine. Methods: One thousand one hundred and fifty samples, divided into four groups of patients receiving either quetiapine immediate- (IR) or extended-release (XR) without or in combination with lamotrigine were compared regarding absolute and dose-adjusted plasma concentrations. Furthermore, samples of intra-individual controls were analyzed. Results: Patients receiving quetiapine IR in combination with lamotrigine showed 31% lower plasma (p = 0.002) and 23% lower dose-adjusted plasma concentrations (p = 0.004) compared to those receiving IR monotherapy. The proportion of patients with quetiapine plasma concentrations below the lower limit of the therapeutic reference range was 50% and 30% in the combination group and in patients receiving monotherapy, respectively (p = 0.03). However, no significant differences regarding plasma concentration (p = 0.13) and dose-adjusted plasma concentration (p = 0.42) were observed in patients with combination vs. monotherapy with the XR formulation of quetiapine. In the intra-individual controls, no trends could be identified, possibly due to insufficient number of samples (p > 0.05). Conclusions: The combination of quetiapine IR with lamotrigine is associated with significantly lower drug concentrations of quetiapine, potentially impacting quetiapine effectiveness. For quetiapine ER, a significant interaction is less likely. [ABSTRACT FROM AUTHOR]

Published
2024
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45. Clozapine-associated pericarditis and pancreatitis in children and adolescents: A systematic literature review and pharmacovigilance study using the VigiBase database

Author

de Filippis, Renato; https://orcid.org/0000-0001-6928-1224, De las Cuevas, Carlos; https://orcid.org/0000-0001-5742-905X, Sanz, Emilio J; https://orcid.org/0000-0001-6788-4435, Schoretsanitis, Georgios; https://orcid.org/0000-0002-3851-4117, Correll, Christoph U; https://orcid.org/0000-0002-7254-5646, de Leon, Jose; https://orcid.org/0000-0002-7756-2314, de Filippis, Renato; https://orcid.org/0000-0001-6928-1224, De las Cuevas, Carlos; https://orcid.org/0000-0001-5742-905X, Sanz, Emilio J; https://orcid.org/0000-0001-6788-4435, Schoretsanitis, Georgios; https://orcid.org/0000-0002-3851-4117, Correll, Christoph U; https://orcid.org/0000-0002-7254-5646, and de Leon, Jose; https://orcid.org/0000-0002-7756-2314

Published
2024

46. A Systematic Review of Clozapine Concentration–Dose Ratio from Therapeutic Drug Monitoring Studies in Children and Adolescents Treated with Clozapine for Mental Disorders

Author

Jiménez-Fernández, Sara; https://orcid.org/0000-0003-1515-2413, Gurpegui, Manuel; https://orcid.org/0000-0002-1262-1627, Correll, Christoph U; https://orcid.org/0000-0002-7254-5646, de Leon, Jose; https://orcid.org/0000-0002-7756-2314, Schoretsanitis, Georgios; https://orcid.org/0000-0002-3851-4117, Jiménez-Fernández, Sara; https://orcid.org/0000-0003-1515-2413, Gurpegui, Manuel; https://orcid.org/0000-0002-1262-1627, Correll, Christoph U; https://orcid.org/0000-0002-7254-5646, de Leon, Jose; https://orcid.org/0000-0002-7756-2314, and Schoretsanitis, Georgios; https://orcid.org/0000-0002-3851-4117

Abstract

Background: Therapeutic drug monitoring of clozapine in children and adolescents has received insufficient attention. Calculation of concentration-to-dose (C/D) ratios from trough steady-state concentrations estimate drug clearance. Methods: A systematic electronic literature search was conducted in 3 article databases from inception until January 10, 2023, and articles reporting clozapine concentrations in children and adolescents were retrieved. The pharmacokinetic quality of the studies was assessed, and clozapine C/D ratios were calculated using the sample mean clozapine dose and concentration. Results: Of the 37 articles of potential interest, only 7 reported clozapine trough and steady-state concentrations. After excluding case reports and a study confounded by fluvoxamine, 4 studies on psychosis from Europe and the United States were included. The clozapine C/D ratios were similar to published adult values and ranged from 0.82 to 1.24 with a weighted mean of 1.08 ng/mL per mg/d. The weighted means were 334 mg/d for the dose and 380 ng/mL for the concentration. The stratified analysis of the weighted mean clozapine C/D ratios from 2 studies showed lower values in 52 male (1.05 ng/mL per mg/d) than in 46 female (1.46 ng/mL per mg/d) children and adolescents, with values similar to those reported for European adult nonsmokers. Two female adolescents had high clozapine C/D ratios (2.54 ng/mL per mg/d), an Asian American patient with borderline obesity and a patient with intellectual disability with low dosage (mean = 102 mg/d) and concentration (mean = 55 ng/mL). Conclusions: Reports on clozapine therapeutic drug monitoring in children and adolescents are limited in number and quality. Future studies should focus on basic pharmacokinetic issues, such as stratification by sex, smoking, and relevant comedications with inductive or inhibitory properties.

Published
2024

47. Revealing the reporting disparity: VigiBase highlights underreporting of clozapine in other Western European countries compared to the UK

Author

De las Cuevas, Carlos; https://orcid.org/0000-0001-5742-905X, Sanz, Emilio J; https://orcid.org/0000-0001-6788-4435, Gross, Jason A; https://orcid.org/0009-0000-9696-8267, Correll, Christoph U; https://orcid.org/0000-0002-7254-5646, Verdoux, Hélène; https://orcid.org/0000-0003-2948-3782, Lally, John; https://orcid.org/0000-0003-3038-0625, de Filippis, Renato; https://orcid.org/0000-0001-6928-1224, Schulte, Peter F J; https://orcid.org/0000-0003-4931-3393, Molden, Espen; https://orcid.org/0000-0001-6190-2751, Arrojo-Romero, Manuel; https://orcid.org/0000-0002-5609-7134, Bostrom, Adrian D; https://orcid.org/0000-0001-8604-9638, Schoretsanitis, Georgios; https://orcid.org/0000-0002-3851-4117, Fernandez-Egea, Emilio; https://orcid.org/0000-0003-4128-8955, de Leon, Jose; https://orcid.org/0000-0002-7756-2314, De las Cuevas, Carlos; https://orcid.org/0000-0001-5742-905X, Sanz, Emilio J; https://orcid.org/0000-0001-6788-4435, Gross, Jason A; https://orcid.org/0009-0000-9696-8267, Correll, Christoph U; https://orcid.org/0000-0002-7254-5646, Verdoux, Hélène; https://orcid.org/0000-0003-2948-3782, Lally, John; https://orcid.org/0000-0003-3038-0625, de Filippis, Renato; https://orcid.org/0000-0001-6928-1224, Schulte, Peter F J; https://orcid.org/0000-0003-4931-3393, Molden, Espen; https://orcid.org/0000-0001-6190-2751, Arrojo-Romero, Manuel; https://orcid.org/0000-0002-5609-7134, Bostrom, Adrian D; https://orcid.org/0000-0001-8604-9638, Schoretsanitis, Georgios; https://orcid.org/0000-0002-3851-4117, Fernandez-Egea, Emilio; https://orcid.org/0000-0003-4128-8955, and de Leon, Jose; https://orcid.org/0000-0002-7756-2314

Abstract

Background: Pharmacovigilance studies indicate clozapine history is marked by adverse drug reactions (ADRs). Objective: In a 2021 article, the United Kingdom (UK) had >90 % of European clozapine-related fatal outcomes in VigiBase, the World Health Organization's pharmacovigilance database. Two possibly opposing hypotheses could explain this disparity: 1) fewer reported fatal outcomes in other Western European countries mainly reflect underreporting to VigiBase, and 2) the higher number of UK reports reflects higher real relative mortality. Methods: VigiBase reports from clozapine's introduction to December 31, 2022, were studied for ADRs and the top 10 causes of fatal outcomes. The UK was compared with 11 other top reporting Western countries (Germany, Denmark, France, Finland, Ireland, Italy, Netherlands, Norway, Spain, Sweden and Switzerland). Nine countries (except Ireland and Switzerland) were compared after controlling for population and clozapine prescriptions. Results: The UK accounted for 29 % of worldwide clozapine-related fatal outcomes, Germany 2 % and <1 % in each of the other countries. The nonspecific label "death" was the top cause in the world (46 %) and in the UK (33 %). "Pneumonia" was second in the world (8 %), the UK (12 %), Ireland (8 %) and Finland (14 %). Assuming that our corrections for population and clozapine use are correct, other countries underreported only 1-10 % of the UK clozapine fatal outcome number. Conclusions: Different Western European countries consistently underreport to VigiBase compared to the UK, but have different reporting/publishing styles for clozapine-related ADRs/fatal outcomes. Three Scandinavian registries suggest lives are saved as clozapine use increases, but this cannot be studied in pharmacovigilance databases.

Published
2024

49. Ein Leitfaden.

Author

Schoretsanitis, Georgios and Paulzen, Michael

Subjects
*DRUG monitoring, *NEUROBEHAVIORAL disorders, *PSYCHOPHARMACOLOGY, *PATIENTS, *DRUGS
Abstract

Bei der Einstellung von Patient:innen auf ein Psychopharmakon kann nicht sicher vorhergesagt werden, ob sie wirklich eine wirksame Medikamentenkonzentration aufbauen oder nicht. Therapeutisches Drug Monitoring kann im Sinne der personalisierten Medizin dabei helfen, individuelle Eigenschaften der Patient:innen zu berücksichtigen und so die Dosierung der angeordneten Psychopharmaka zu optimieren. [ABSTRACT FROM AUTHOR]

Published
2024
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50. The European psychiatric association (EPA) – early career psychiatrists committee survey on trainees' and early-career psychiatrists' attitudes towards therapeutic drug monitoring (TDM) use and utility during antipsychotic treatment.

Author

Schoretsanitis, Georgios, Correll, Christoph U., Agorastos, Agorastos, Compaired Sanchez, Alejandro, Erzin, Gamze, Grigoras, Ruxandra M., Grizelj Benussi, Mateja, Gondek, Tomasz M., Guloksuz, Sinan, Højlund, Mikkel, Jerotic, Stefan, Kilic, Ozge, Metaj, Enita, Sidhu, Deshwinder Singh, Skandali, Nikolina, Skuhareuski, Aliaksei, Tveito, Marit, Wolthusen, Rick P. F., Chumakov, Egor, and de Filippis, Renato

Subjects
*DRUG monitoring, *ATTITUDES of medical personnel, *NOCEBOS, *PSYCHIATRISTS, *EXPLORATORY factor analysis, *HIGH-income countries
Abstract

This survey assessed psychiatry residents'/early-career psychiatrists' attitudes towards the utility of therapeutic drug monitoring (TDM) of antipsychotics. A previously developed questionnaire on attitudes on TDM utility during antipsychotic treatment was cross-sectionally disseminated by national coordinators between 01/01/2022–31/12/2023. The frequency of using TDM for antipsychotics other than clozapine was the main outcome in a linear regression analysis, including sex, clinical setting, caseload, and factors generated by an exploratory factor analysis. Comparisons between residents and early-career psychiatrists, respondents working in in- and outpatient settings, and low-/middle- and high–income countries were performed. Altogether, 1,237 respondents completed the survey, with 37.9% having never used TDM for antipsychotics. Seven factors explained 41% of response variance; six of them were associated with frequency of TDM use (p < 0.05). Items with highest loadings for factors included clinical benefits of TDM (factors A and E: 0.7), negative expectations for beliefs of patients towards TDM (factor B: 0.6–0.7), weak TDM scientific evidence (factor C: 0.8), and TDM availability (factor D: −0.8). Respondents from low-/middle-income countries were less likely to frequently/almost always use TDM compared to high-income countries (9.4% vs. 21.5%, p < 0.001). TDM use for antipsychotics was poor and associated with limited knowledge and insufficient availability. [ABSTRACT FROM AUTHOR]

Published
2024
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