Jin YW, Zhang Y, Wang J, Jiang L, He SM, Zhang C, Wang DD. Effects of paroxetine on aripiprazole and individualized administration in depressed patients based on model-informed precision dosing. World J Psychiatry 2026; 16(7): 117458 [DOI: 10.5498/wjp.117458]
Corresponding Author of This Article
Dong-Dong Wang, PhD, Adjunct Professor, Principal Investigator, Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy and School of Pharmacy, Xuzhou Medical University, No. 209 Tongshan Road, Xuzhou 221004, Jiangsu Province, China. 13852029591@163.com
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Jin YW, Zhang Y, Wang J, Jiang L, He SM, Zhang C, Wang DD. Effects of paroxetine on aripiprazole and individualized administration in depressed patients based on model-informed precision dosing. World J Psychiatry 2026; 16(7): 117458 [DOI: 10.5498/wjp.117458]
Ying-Wei Jin, Department of Pharmacy, The Suqian Clinical College of Xuzhou Medical University, Suqian 223800, Jiangsu Province, China
Yue Zhang, Jie Wang, Lei Jiang, Dong-Dong Wang, Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy and School of Pharmacy, Xuzhou Medical University, Xuzhou 221004, Jiangsu Province, China
Su-Mei He, Department of Pharmacy, Suzhou Research Center of Medical School, Suzhou Hospital, Affiliated Hospital of Medical School, Nanjing University, Suzhou 215153, Jiangsu Province, China
Cun Zhang, Department of Pharmacy, Xuzhou Oriental Hospital Affiliated to Xuzhou Medical University, Xuzhou 221004, Jiangsu Province, China
Co-corresponding authors: Su-Mei He and Dong-Dong Wang.
Author contributions: Jin YW and Zhang Y analyzed the data and wrote the manuscript, they contributed equally to this article and are the co-first authors of this manuscript; Jin YW, Zhang Y, Wang J, Jiang L, He SM, Zhang C, and Wang DD performed the research; He SM and Wang DD designed the study, they contributed equally to this article, they are the co-corresponding authors of this manuscript; and all the authors contributed to the interpretation of the results, manuscript revision, and approved the final version of the manuscript.
Supported by the Science and Technology Program of Xuzhou, No. KC25105; Basic Science (Natural Science) Project of Higher Education Institutions in Jiangsu Province, No. 25KJD310004; Suzhou Applied Basic Research Science and Technology Innovation Project, No. SYWD2024258; Xuzhou Medical University Research Project on Reform of Postgraduate Education and Teaching, No. XYJGKT202506; and Xuzhou Medical University Teaching Academic Research Topics, No. 2024ZDKT02-Y03.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Xuzhou Oriental Hospital Affiliated to Xuzhou Medical University, approval No. 20220725011.
Informed consent statement: The informed consent was waived by the Institutional Review Board.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
STROBE statement: The authors have read the STROBE Statement-checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-checklist of items.
Data sharing statement: Data used in this study can be available from the corresponding author upon request.
Corresponding author: Dong-Dong Wang, PhD, Adjunct Professor, Principal Investigator, Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy and School of Pharmacy, Xuzhou Medical University, No. 209 Tongshan Road, Xuzhou 221004, Jiangsu Province, China. 13852029591@163.com
Received: December 8, 2025 Revised: January 19, 2026 Accepted: March 5, 2026 Published online: July 19, 2026 Processing time: 205 Days and 1.1 Hours
Abstract
BACKGROUND
Aripiprazole can be used as an adjunctive treatment for depression, however, the drug-drug interactions (DDI) and initial dosage of aripiprazole in depressed patients remains unclear.
AIM
To explore DDI and optimal initial dosage of aripiprazole in depressed patients.
METHODS
Eighty- seven depressed patients were included and model-informed precision dosing was used to analyze potential DDI and recommend optimal initial dosage regimen of aripiprazole in depressed patients.
RESULTS
In the final aripiprazole model-informed precision dosing model, weight and paroxetine hydrochloride tablet influenced the clearance rate of aripiprazole in depressed patients, and aripiprazole clearance rate decreased 53.3% in depressed patients taking paroxetine hydrochloride tablet. Further, for depressed patients without paroxetine hydrochloride tablet, 0.5 mg/kg and 0.4 mg/kg aripiprazole were recommended to 40-80 kg depressed patients and 80-120 kg depressed patients, respectively. For depressed patients with paroxetine hydrochloride tablet, 0.3 mg/kg aripiprazole was recommended to 40-120 kg depressed patients.
CONCLUSION
Paroxetine hydrochloride reduces the clearance rate of aripiprazole and, when taking paroxetine hydrochloride tablet simultaneously, the dosage of aripiprazole should be reduced in depressed patients.
Core Tip: This study explores drug-drug interactions and optimal initial dosage of aripiprazole in depressed patients based on model-informed precision dosing. When depressed patients take paroxetine hydrochloride tablet at the same time, it will reduce the clearance rate of aripiprazole. Aripiprazole clearance rate decreases 53.3% in depressed patients taking paroxetine hydrochloride tablet. Therefore, when taking paroxetine hydrochloride tablet simultaneously, the dosage of aripiprazole should be reduced in depressed patients.
Citation: Jin YW, Zhang Y, Wang J, Jiang L, He SM, Zhang C, Wang DD. Effects of paroxetine on aripiprazole and individualized administration in depressed patients based on model-informed precision dosing. World J Psychiatry 2026; 16(7): 117458
Depressive disorder is a mental disorder characterized by significant and persistent low mood[1]. Globally, the incidence of depressive disorder is showing a significant upward trend[2,3]. The clinical features of depressive disorder include: Emotional disorders such as long-term low mood, loss of interest, accompanied by a sense of hopelessness or emptiness, and in severe cases, loss of the ability to take care of oneself[4]. Cognitive function impairment such as inability to concentrate, memory decline, and decreased decision-making ability, which affects work and study efficiency[5,6]. Physical symptoms such as sleep disorders (insomnia or excessive sleepiness), changes in appetite, chronic pain and fatigue[7-12]. Social function decline such as avoidance of social activities, breakdown of interpersonal relationships, and formation of a vicious cycle of self-isolation[13].
Mild depression can be treated with cognitive behavioral therapy, while moderate to severe cases require the combination of antidepressant drugs. Currently, the commonly used effective antidepressant drugs in clinical practice include selective serotonin reuptake inhibitors (such as paroxetine hydrochloride, sertraline hydrochloride, fluvoxamine maleate, fluoxetine hydrochloride, citalopram hydrobromide)[14-17], serotonin and norepinephrine reuptake inhibitors (such as venlafaxine, duloxetine)[18], and new rapid-acting antidepressants (such as esketamine)[19].
Aripiprazole is an atypical antipsychotic drug, mainly used for the treatment of schizophrenia and bipolar affective disorder, and can also be used as an adjunctive treatment for depressive disorder[20-29]. The application of aripiprazole in the treatment of depressive disorder is mainly based on its unique pharmacological mechanism and clinical indications. As an atypical antipsychotic drug, aripiprazole partially activates dopamine D2 receptors and 5-hydroxytryptamine 1A receptors, while antagonizing 5-hydroxytryptamine 2A receptors, and bidirectionally regulates the dopamine and serotonin systems, thereby improving mood and cognitive functions[30-32]. This mechanism is particularly effective for patients with depressive disorder accompanied by psychotic symptoms (such as delusions and auditory hallucinations). When traditional antidepressants are ineffective, aripiprazole can be used as an enhancer to enhance the antidepressant effect and improve physical symptoms. Clinical trials have shown that combined use can significantly improve the symptoms of depressed patients[33-36].
However, when combined with other drugs, it is still unclear whether there are potential drug-drug interactions (DDI) for aripiprazole in depressed patients and how to formulate the optimal individualized dosing plan in clinical practice. Therefore, this study aims to explore the DDI and the optimal initial dosage of aripiprazole in depressed patients based on model-informed precision dosing (MIPD).
MATERIALS AND METHODS
Data collection
Depressed patients treated by aripiprazole between August 2020 and December 2024 from Xuzhou Oriental Hospital Affiliated to Xuzhou Medical University were collected, retrospectively, which was approved by the Research Ethics Committee of Xuzhou Oriental Hospital Affiliated to Xuzhou Medical University. In this study, aripiprazole concentrations of depressed patients, physiological and biochemical data, and drug combination data were included.
Modeling
MIPD was used for solving this problem, and one of the main MIPD tools, population pharmacokinetic (PPK) model was used to build the potential DDI model of aripiprazole with combination drugs using non-linear mixed effect modeling (NONMEM, edition 7, ICON Development Solutions, Ellicott City, MD, United States) software with a first-order conditional estimation method. Apparent oral clearance (CL/F), volume of distribution (V/F), and absorption rate constant (fixed at 1.06/hour[37]) were included in pharmacokinetic parameters.
The inter-individual variability was shown in Equation (1): Ai = TV(A) × exp (ηi) (1).
A1 was the individual parameter value. TV(A) was the typical individual parameter value. ηi was symmetrical distribution, which was random term with zero mean and variance ω2.
The random residual variability was shown in Equation (2): Bi = Ci + ε1 (2).
Bi was the observed concentration. Ci was the individual predicted concentration. ε1 was symmetrical distribution, which was random term with zero mean and variance σ2.
The relationship of pharmacokinetic parameters with weight was shown in Equation (3): Di = Dstd × (Ei /Estd)F (3).
Di was the i-th individual parameter. Ei was the i-th individual weight. Estd was the standard weight of 70 kg. Dstd was the typical individual parameter, whose weight was Estd. F was the allometric coefficient: 0.75 for the CL/F and 1 for the V/F.
The pharmacokinetic parameters between continuous covariates or categorical covariates were shown in Equation (4) and (5), respectively: Gi = TV(G) × (Covi /Covm)H (4). Gi = TV(G) × (1 + H × Covi) (5).
Gi was the individual parameter value. TV(G) was the typical individual parameter value. H was the parameter to be estimated; Covi was the covariate of the i-th individual. Covm was the population median for the covariate.
The covariate model was analyzed using a stepwise way, where the change of objective function value (OFV) was selected as the covariate inclusion and exclusion criteria. The OFV decrease was more than 6.63 (P < 0.01) and OFV increase was more than 10.8 (P < 0.001) were confirmed inclusion standard and exclusion standard, respectively.
Model validation
Observations vs population predictions, observations vs individual predictions, absolute value of weighted residuals of individual vs individual predictions, weighted residuals vs time, observations/predictions vs time, density vs weighted residuals, quantiles of weighted residuals vs quantiles of normal, visual predictive check of model, individual plots were used to carry out model validation of the aripiprazole final model in depressed patients. Additionally, the medians and 2.5th-97.5th percentiles of the results from bootstrap (n = 1000) were used for comparing with final model parameters.
Simulation
The present study used Monte Carlo simulation to simulate aripiprazole concentrations of depressed patients under different dosage regimens, where the therapeutic range of aripiprazole was 100-350 ng/mL[38]. We found that paroxetine hydrochloride tablet influenced the clearance rate of aripiprazole in depressed patients. Thus, based on whether paroxetine hydrochloride tablet was used in combination or not, we simulated two situations: (1) Depressed patients without paroxetine hydrochloride tablet; and (2) Depressed patients with paroxetine hydrochloride tablet.
MIPD was used for simulating 0.1 mg/kg, 0.2 mg/kg, 0.3 mg/kg, 0.4 mg/kg, 0.5 mg/kg, 0.6 mg/kg, 0.7 mg/kg and 0.8 mg/kg aripiprazole for 40 kg, 60 kg, 80 kg, 100 kg, 120 kg depressed patients. Every simulation scenario included 1000 virtual depressed patients. The probability of realizing aripiprazole therapeutic range in depressed patients under different simulated dosages were selected as the evaluation criterion.
RESULTS
Patient data
Eighty-seven depressed patients were included for analysis, where 30 men and 57 women, whose age were from 12.73-72.21 years old, and weight were from 40.00-108.00 kg. Demographic data of depressed patients, and drug combination in depressed patients were shown in Tables 1 and 2, respectively.
Table 1 Demographic data of depressed patients with aripiprazole (n = 87), mean ± SD.
DDI evaluation process of aripiprazole in depressed patients was shown in Supplementary Table 1. The final aripiprazole model of depressed patients were shown in Equations (6) and (7): CL/F = 3.12 × (weight/70)0.75 × [1-0.533 × paroxetine hydrochloride tablet (PAR)] (6). V/F = 287 × (weight /70) (7).
PAR depressed patients took paroxetine hydrochloride tablet, PAR was 1, otherwise PAR was 0.
Model evaluation
Figure 1 showed observations vs population predictions, observations vs individual predictions, absolute value of weighted residuals of individual vs individual predictions, weighted residuals vs time, observations/predictions vs time, density vs weighted residuals, quantiles of weighted residuals vs quantiles of normal, visual predictive check of model. Figure 2 showed individual plots. Table 3 showed bootstrap validation. The above results indicated aripiprazole model of depressed patients were accurate and reliable.
Figure 1 Model evaluation.
A: Observations vs population predictions; B: Observations vs individual predictions; C: Absolute value of weighted residuals of individual vs individual predictions; D: Weighted residuals vs time; E: Observations/predictions vs time; F: Density vs weighted residuals; G: Quantiles of weighted residuals vs quantiles of normal; H: Visual predictive check of model. iWRES: Weighted residuals of individual.
Figure 3 was aripiprazole clearance in depressed patients, where line a was depressed patients without paroxetine hydrochloride tablet, and line b was depressed patients with paroxetine hydrochloride tablet. The ratios of aripiprazole clearance were 1:0.467 in depressed patients without paroxetine hydrochloride tablet and depressed patients with paroxetine hydrochloride tablet. Under the same weight condition, aripiprazole clearance rate decreased 53.3% in depressed patients taking paroxetine hydrochloride tablet. Figures 4 and 5 were aripiprazole concentrations in depressed patients without paroxetine hydrochloride tablet under different simulated dosages and aripiprazole concentrations in depressed patients with paroxetine hydrochloride tablet under different simulated dosages, respectively. Figure 6 was probability of realizing aripiprazole therapeutic range in depressed patients under different simulated dosages. Furthermore, for depressed patients without paroxetine hydrochloride tablet, 0.5 mg/kg and 0.4 mg/kg aripiprazole were recommended to 40-80 kg depressed patients and 80-120 kg depressed patients, respectively. For depressed patients with paroxetine hydrochloride tablet, 0.3 mg/kg aripiprazole was recommended to 40-120 kg depressed patients, which was shown in Table 4.
Figure 6 Probability of realizing aripiprazole therapeutic range in depressed patients under different simulated dosages.
A: Depressed patients without paroxetine hydrochloride tablet; B: Depressed patients with paroxetine hydrochloride tablet.
Table 4 Initial dosage recommendation of aripiprazole in depressed patients.
Without paroxetine hydrochloride tablet
With paroxetine hydrochloride tablet
Body weight (kg)
Dosage (mg/kg/day)
Probability to achieve the target concentrations (%)
Body weight (kg)
Dosage (mg/kg/day)
Probability to achieve the target concentrations (%)
The clinical use of aripiprazole mainly relies on its drug concentration level. Generally, the concentration is monitored through therapeutic drug monitoring method, and the next administration plan is further adjusted based on the results[39-43]. However, there are no available aripiprazole therapeutic drug monitored for the initial dosage. Therefore, the individualized administration of aripiprazole for depressed patients poses a challenge.
MIPD is an individualized medication approach based on quantitative pharmacology and mathematical modeling techniques. By integrating multi-dimensional information such as patient physiology, pathology, and genetics, it optimizes the dosing plan to enhance efficacy and safety. Its core technology utilizes mathematical modeling and simulation to integrate patient characteristics, pharmacokinetic/pharmacodynamic data, and disease status to predict individualized dosage plans. Compared to empirical medication, MIPD can reduce the risk of insufficient or excessive toxicity of drugs. Specifically, MIPD is based on application scenarios and research techniques, including but not limited to PPK model, pharmacokinetic/pharmacodynamic model, population pharmacodynamic model, physiologically-based pharmacokinetic model, model-based meta-analysis, and artificial intelligence[44].
In terms of the applicability of MIPD, PPK currently holds a pivotal position in the research of DDI and individualized drug delivery. For example, Li et al[45] reported PPK of ruxolitinib in children with hemophagocytic lymphohistiocytosis: Focus on the DDI. Shore et al[46] reported evaluation of clinically relevant DDI and PPK of darolutamide in patients with nonmetastatic castration-resistant prostate cancer: Results of pre-specified and post hoc analyses of the phase III ARAMIS trial. Courlet et al[47] reported escitalopram PPK in people living with human immunodeficiency virus and in the psychiatric population: DDI and probability of target attainment. Chen et al[48] reported DDI and initial dosage optimization of quetiapine in patients with depression: A real-world study. Zhang et al[49] reported DDI of paroxetine on olanzapine and initial dosage optimization in patients with major depressive disorder based on PPK. Based on this, we utilized PPK, one of the main MIPD tools to explore the drugs that may have potential interactions with aripiprazole in depressed patients, and we further studied the individualized dosage regimens of aripiprazole under different administration scenarios.
In this study, we collected a total of 87 depressed patients who were using aripiprazole, including 30 men and 57 women. In the final aripiprazole MIPD model, the CL/F and V/F of aripiprazole in depressed patients were 3.12 L/hour and 287 L, respectively. Additionally, weight and paroxetine hydrochloride tablet influenced the clearance rate of aripiprazole in depressed patients, the ratios of aripiprazole clearance were 1:0.467 in depressed patients without paroxetine hydrochloride tablet and depressed patients with paroxetine hydrochloride tablet.
This phenomenon can be explained from the perspective of pharmacological effects. Paroxetine, as a cytochrome P450 2D6 inhibitor, significantly affects the pharmacokinetic process of aripiprazole[50-55]. The specific mechanism is as follows: Paroxetine inhibits the activity of the CYP2D6 enzyme, significantly reducing the metabolic rate of aripiprazole, resulting in an increase of aripiprazole blood concentration. This inhibitory effect may cause the concentration of aripiprazole to reach its peak earlier and increase the risk of drug accumulation. Therefore, in the process of individualized dosage determination, the dosage of aripiprazole for depressed patients who was concurrently taking paroxetine needed to be reduced. This study simulated two scenarios based on whether paroxetine was combined: Depressed patients did not take paroxetine, and depressed patients took paroxetine and aripiprazole simultaneously. Additionally, for depressed patients without paroxetine hydrochloride tablet, 0.5 mg/kg and 0.4 mg/kg aripiprazole were recommended to 40-80 kg depressed patients and 80-120 kg depressed patients, respectively. For depressed patients with paroxetine hydrochloride tablet, 0.3 mg/kg aripiprazole was recommended to 40-120 kg depressed patients.
Of course, this study also had certain limitations. Firstly, the number of participants in the study was limited, however the number of patients was sufficient according to the similar studies. For example, Loo et al’s study[56] included 83 patients with hematological disorders, Fan et al’s study[57] conducted a retrospective PPK analysis in 87 neurosurgical patients, Sun et al’s study[58] included 86 sepsis patients, Kirubakaran et al’s study[59] collected 87 heart transplant recipients. In addition, CYP2D6 polymorphisms were related to aripiprazole variations and this information was not included in the present dataset, which may have a slightly negative impact on the accuracy of the research. However, the model with genetic polymorphisms might not be practical for simulating drug dosage data in the real world because no routine genetic testing had been conducted in patients treated with aripiprazole and genetic data were often missing. In other words, the present model without genetic polymorphisms may have better clinical and practical value in the real world. Furthermore, since only the trough concentration was available in clinical settings, the absorption rate constant value of aripiprazole was fixed according to the literature. Finally, it was a retrospective single-center study. In future research, multi-center prospective clinical trials need to be conducted to verify the results.
CONCLUSION
This study explores DDI and optimal initial dosage of aripiprazole in depressed patients based on MIPD. When depressed patients take paroxetine hydrochloride tablet at the same time, it will reduce the clearance rate of aripiprazole. Aripiprazole clearance rate decreases 53.3% in depressed patients taking paroxetine hydrochloride tablet. Therefore, when taking paroxetine hydrochloride tablet simultaneously, the dosage of aripiprazole should be reduced in depressed patients. Further, for depressed patients without paroxetine hydrochloride tablet, 0.5 mg/kg and 0.4 mg/kg aripiprazole are recommended to 40-80 kg depressed patients and 80-120 kg depressed patients, respectively. For depressed patients with paroxetine hydrochloride tablet, 0.3 mg/kg aripiprazole is recommended to 40-120 kg depressed patients.
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