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已发表论文
药物相互作用与抑郁症患者氯氮平个体化治疗：来自真实世界数据的见解
Authors Jiang L, Zhang Y, Wang J, Zhang C, Wang D
Received 18 June 2025
Accepted for publication 22 October 2025
Published 4 November 2025 Volume 2025:19 Pages 9809—9823
DOI https://doi.org/10.2147/DDDT.S547878
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Manfred Ogris
Lei Jiang,1 Yue Zhang,2 Jie Wang,2 Cun Zhang,3 Dongdong Wang2
1Department of Pharmacy, Taixing Clinical College of Xuzhou Medical University, Taixing, Jiangsu, 225400, People’s Republic of China; 2Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy & School of Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu, 221004, People’s Republic of China; 3Department of Pharmacy, Xuzhou Oriental Hospital Affiliated to Xuzhou Medical University, Xuzhou, Jiangsu, 221004, People’s Republic of China
Correspondence: Lei Jiang, Department of Pharmacy, Taixing Clinical College of Xuzhou Medical University, Taixing, Jiangsu, 225400, People’s Republic of China, Email 15240208820@163.com
Objective: Clozapine is widely used in patients with depression but its metabolism via multiple hepatic enzymes raises concerns about drug–drug interactions (DDIs). The extent of these interactions in real-world clinical settings remains unclear.
Methods: This research involved 29 patients with depression from the real world, utilizing their clozapine concentration data, physiological and biochemical data, and drug combination data to construct a DDI evaluation model using the population pharmacokinetics (PPK) method and NONMEM software.
Results: The results of our research reveal that fluvoxamine maleate has a noteworthy DDI with clozapine, and fluvoxamine reduced clozapine clearance by 56.5%, necessitating substantial dose reductions. Furthermore, clozapine doses of 9 mg/kg, 8 mg/kg, 7 mg/kg and 6 mg/kg are recommended for 40– 47 kg, 47– 70 kg, 70– 100 kg and 100– 120 kg patients with depression not takingw fluvoxamine maleate, respectively. Clozapine doses of 3 mg/kg and 2 mg/kg are recommended for 40– 70 kg and 70– 120 kg patients with depression taking fluvoxamine maleate, respectively.
Conclusion: This study provides the first real-world evidence to guide safe and individualized clozapine dosing in patients with depression, particularly in the context of fluvoxamine co-administration. When patients with depression patient are treated with fluvoxamine maleate, the dosage of clozapine needs to be reduced.
Keywords: drug–drug interactions, individualized therapy, clozapine, depression, real-world
1Department of Pharmacy, Taixing Clinical College of Xuzhou Medical University, Taixing, Jiangsu, 225400, People’s Republic of China; 2Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy & School of Pharmacy, Xuzhou Medical University, Xuzhou, Jiangsu, 221004, People’s Republic of China; 3Department of Pharmacy, Xuzhou Oriental Hospital Affiliated to Xuzhou Medical University, Xuzhou, Jiangsu, 221004, People’s Republic of China
Correspondence: Lei Jiang, Department of Pharmacy, Taixing Clinical College of Xuzhou Medical University, Taixing, Jiangsu, 225400, People’s Republic of China, Email 15240208820@163.com
Objective: Clozapine is widely used in patients with depression but its metabolism via multiple hepatic enzymes raises concerns about drug–drug interactions (DDIs). The extent of these interactions in real-world clinical settings remains unclear.
Methods: This research involved 29 patients with depression from the real world, utilizing their clozapine concentration data, physiological and biochemical data, and drug combination data to construct a DDI evaluation model using the population pharmacokinetics (PPK) method and NONMEM software.
Results: The results of our research reveal that fluvoxamine maleate has a noteworthy DDI with clozapine, and fluvoxamine reduced clozapine clearance by 56.5%, necessitating substantial dose reductions. Furthermore, clozapine doses of 9 mg/kg, 8 mg/kg, 7 mg/kg and 6 mg/kg are recommended for 40– 47 kg, 47– 70 kg, 70– 100 kg and 100– 120 kg patients with depression not takingw fluvoxamine maleate, respectively. Clozapine doses of 3 mg/kg and 2 mg/kg are recommended for 40– 70 kg and 70– 120 kg patients with depression taking fluvoxamine maleate, respectively.
Conclusion: This study provides the first real-world evidence to guide safe and individualized clozapine dosing in patients with depression, particularly in the context of fluvoxamine co-administration. When patients with depression patient are treated with fluvoxamine maleate, the dosage of clozapine needs to be reduced.
Keywords: drug–drug interactions, individualized therapy, clozapine, depression, real-world