He SM, Zhang CX, Jin YW, Jiang L, Zhang C, Jiang YG, Wang DD. Effect of sodium valproate on aripiprazole pharmacokinetics and initial dosage optimization in bipolar disorder. World J Psychiatry 2026; 16(8): 120073 [DOI: 10.5498/wjp.v16.i8.120073]
Corresponding Author of This Article
Dong-Dong Wang, PhD, Adjunct Professor, 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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He SM, Zhang CX, Jin YW, Jiang L, Zhang C, Jiang YG, Wang DD. Effect of sodium valproate on aripiprazole pharmacokinetics and initial dosage optimization in bipolar disorder. World J Psychiatry 2026; 16(8): 120073 [DOI: 10.5498/wjp.v16.i8.120073]
Su-Mei He, Yi-Guo Jiang, Department of Pharmacy, Suzhou Research Center of Medical School, Suzhou Hospital, Affiliated Hospital of Medical School, Nanjing University, Suzhou 215153, Jiangsu Province, China
Chang-Xiao Zhang, Department of Geriatrics, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200336, China
Ying-Wei Jin, Department of Pharmacy, The Suqian Clinical College of Xuzhou Medical University, Suqian 223800, Jiangsu Province, China
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
Cun Zhang, Department of Pharmacy, Xuzhou Oriental Hospital Affiliated to Xuzhou Medical University, Xuzhou 221004, Jiangsu Province, China
Co-corresponding authors: Yi-Guo Jiang and Dong-Dong Wang.
Author contributions: He SM and Zhang CX analyzed the data and drafted the manuscript, and they made equal contributions to this work as co-first authors; He SM, Zhang CX, Jin YW, Jiang L, Zhang C, Jiang YG, and Wang DD performed the research, contributed to data interpretation, and revised the manuscript; Jiang YG and Wang DD designed the study, and they contributed equally to this work as co-corresponding authors. All authors approved the final version to publish.
Supported by Suzhou Applied Basic Research Science and Technology Innovation Project, No. SYWD2024258; Basic Science (Natural Science) Project of Higher Education Institutions in Jiangsu Province, No. 25KJD310004; Jiangsu Province Higher Education Informatization Research Project, No. 2023JSETKT136; Xuzhou Medical University Research Project on Reform of Postgraduate Education and Teaching, No. XYJGKT202506; and Xuzhou Medical University Teaching Academic Research Project, 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, 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.
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, 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: February 14, 2026 Revised: March 21, 2026 Accepted: April 15, 2026 Published online: August 19, 2026 Processing time: 166 Days and 23.3 Hours
Abstract
BACKGROUND
Aripiprazole provides clinical benefits in patients with bipolar disorder (BD).
AIM
To explore drug-drug interactions and optimize the initial dosage of aripiprazole in patients with BD.
METHODS
Patients with BD treated with aripiprazole were retrospectively analyzed. A virtual clinical trial approach was applied, with a population pharmacokinetic model developed using non-linear mixed effects modeling.
RESULTS
Weight and coadministration of sodium valproate sustained-release tablets were identified as significant factors influencing aripiprazole clearance. Aripiprazole clearance increased by 66.7% in patients receiving sodium valproate sustained-release tablets. For patients weighing 40-120 kg without sodium valproate, the optimal initial dosage was 0.3 mg/kg, and for those receiving sodium valproate, the optimal initial dosage was 0.4 mg/kg.
CONCLUSION
This study explored drug-drug interactions and initial dosage optimization of aripiprazole in patients with BD using a virtual clinical trial approach. Coadministration of sodium valproate sustained-release tablets increases aripiprazole clearance in patients with BD, indicating that a higher initial dosage of aripiprazole may be required.
Core Tip: This study aims to explore drug-drug interactions and initial dosage optimization of aripiprazole in patients with bipolar disorder (BD). Aripiprazole clearance rate increases 66.7% in patients with BD taking sodium valproate sustained-release tablet. The present study explores the drug-drug interactions and initial dosage optimization of aripiprazole in patients with BD based on virtual clinical trial for the first time. When sodium valproate sustained-release tablet is used in combination, the clearance of aripiprazole in patients with BD is accelerated, and the dosage of aripiprazole in patients with BD need to be increased.
Citation: He SM, Zhang CX, Jin YW, Jiang L, Zhang C, Jiang YG, Wang DD. Effect of sodium valproate on aripiprazole pharmacokinetics and initial dosage optimization in bipolar disorder. World J Psychiatry 2026; 16(8): 120073
Bipolar disorder (BD) is a serious mental illness with a global prevalence rate of approximately 1%-2%[1-4]. The core symptoms of BD include manic episodes, depressive episodes, and simultaneous or rapid alternations between manic and depressive symptoms. In clinical practice, the treatment goals of BD are to alleviate symptoms, prevent recurrence, and restore patients’ functional status[5]. To achieve these therapeutic goals, the treatment plan must be comprehensive, with pharmacotherapy serving as the main treatment modality for BD. Currently, the challenge in treating BD lies in enhancing patient responsiveness, alleviating symptoms, restoring functional outcomes, and preventing relapse[6-8].
Aripiprazole, a second-generation antipsychotic, is often chosen as a first-line treatment for first-episode psychosis and has demonstrated good efficacy[9-13]. Woo et al[14] found that aripiprazole can reduce the recurrence of mood episodes and provide clinical benefits for patients with BD. Goto et al[15] found, through real-world studies, that aripiprazole reduces the overall re-hospitalization rate in patients with BD. Other studies have also found that the use of aripiprazole can provide certain benefits to patients with BD[16-20].
In terms of pharmacokinetics, aripiprazole is mainly metabolized by cytochrome P450 (CYP) 2D6 and CYP3A4 enzymes[21,22]. There are significant inter- and intra-individual differences in aripiprazole pharmacokinetics[23]. Aripiprazole plasma concentration is associated with both therapeutic effects and adverse reactions, and high concentrations are more likely to trigger severe or persistent abnormalities in the nervous and mental systems, as well as metabolic disturbances. Furthermore, during clinical treatment, drugs that affect the metabolism or transport of aripiprazole may lead to potential drug-drug interactions (DDI), thereby influencing the concentration and dosage of aripiprazole in patients with BD. Given this context, the present study aimed to explore DDI and initial dosage optimization of aripiprazole in patients with BD.
MATERIALS AND METHODS
Data collection
Patients with BD treated with aripiprazole between September 2020 and September 2024 at Xuzhou Oriental Hospital Affiliated to Xuzhou Medical University were retrospectively analyzed. The collected data included aripiprazole concentrations, physiological and biochemical parameters, and concomitant medication data.
Modeling
A virtual clinical trial (VCT) approach was employed to achieve the study objectives. A population pharmacokinetic model was developed using nonlinear mixed-effects modeling software (NONMEM, version 7, ICON Development Solutions, Ellicott City, MD, United States) with the first-order conditional estimation method. The pharmacokinetic parameters included apparent oral clearance (CL/F), volume of distribution (V/F), and absorption rate constant (Ka), which was fixed at 1.06/hour[24,25].
Inter-individual variability was described using equation (1): Ei = TV(E) × exp(ηi) (1), where Ei represents the individual parameter value, TV(E) represents the typical value, and ηi represents symmetrical distribution, which is a random term with zero mean and variance ω2.
Residual variability was described using equation (2): Hi = Qi + Qi × ε1 + ε2 (2), where Hi represents the observed concentration, Qi represents the individual predicted concentration, and ε1 and ε2 represent symmetrical distribution, which are random terms with zero mean and variance σ2.
The relationship between pharmacokinetic parameters and body weight was described using an allometric model (equation 3): Pi = Pstd × (Ui /Ustd)X (3), where Pi represents the parameter for the i-th individual, Ui represents the i-th individual’s weight, Ustd represents the standard weight (70 kg), and Pstd represents the typical parameter value corresponding to Ustd. The allometric exponent X was fixed at 0.75 for the CL/F and 1 for V/F[26].
The relationships between pharmacokinetic parameters and continuous or categorical covariates were described by equations (4) and (5), respectively: Mi = TV(M) × (Covi/Covm)Z (4); Mi = TV(M) × (1 + Z × Covi) (5), where Mi represents the individual parameter value, TV(M) represents the typical value, Z represents the parameter to be estimated, Covi represents the covariate for the i-th individual, and Covm represents the population median of the covariate.
A stepwise covariate modeling approach was applied. Changes in the objective function value (OFV) were used as the covariate inclusion criteria. A decrease in OFV > 6.63 (P < 0.01) was considered statistically significant for covariate inclusion, whereas an increase in OFV > 10.8 (P < 0.001) was used as the criterion for covariate exclusion.
Model validation
Visualized diagnostics were used to evaluate the final model of aripiprazole in patients with BD, including observations vs individual predictions, conditional weighted residuals (WRES) vs individual predictions, conditional WRES vs time, density vs WRES, quantiles of WRES vs quantiles of normal, and visual predictive check, as well as individual plots. In addition, the medians and 2.5th-97.5th percentiles from a bootstrap analysis (n = 1000) were compared with the final model parameters.
Simulation
Monte Carlo simulations were performed to predict aripiprazole concentrations under different dosing regimens. The therapeutic window of aripiprazole was defined as 100-350 ng/mL[27,28]. In this study, weight and coadministration of sodium valproate sustained-release tablets were identified as factors influencing aripiprazole clearance. Therefore, two scenarios were simulated: (1) Patients with BD without receiving sodium valproate sustained-release tablets; and (2) Patients with BD receiving sodium valproate sustained-release tablets. VCT was used to simulate patients with body weights of 40, 60, 80, 100, and 120 kg, with 1000 virtual patients in each weight group. Simulated dosage regimens of aripiprazole included 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, and 0.8 mg/kg. The probability of achieving concentrations within the therapeutic window was used as the evaluation criterion.
RESULTS
Patient data
A total of 24 patients with BD (15 men and 9 women) were included in the analysis. The age ranged from 18.05 years to 66.50 years, and body weight ranged from 50.00 kg to 105.00 kg. The demographic characteristics and concomitant medications of patients with BD are shown in Tables 1 and 2, respectively.
Table 1 Demographic data of bipolar disorder patients receiving aripiprazole (n = 24).
Drug-drug interaction evaluation process of aripiprazole in patients with bipolar disorder is shown in Supplementary Table 1. Equations (6) and (7) describe the final model for patients with BD: CL/F = 2.42 × (weight/70)0.75 × (1 + 0.667 × VPA) (6); V/F = 425 × (weight/70) (7), VPA represents the use of sodium valproate sustained-release tablet. VPA = 1 when patients with BD received sodium valproate sustained-release tablet, whereas VPA = 0 when they did not.
Model evaluation
The following plots are shown in Figure 1: Observations vs individual predictions, conditional WRES vs individual predictions, conditional WRES vs time, density vs WRES, quantiles of WRES vs quantiles of normal, and visual predictive checks of the model. Individual plots are shown in Figure 2. Bootstrap validation is shown in Table 3. The above results indicate that the aripiprazole model for patients with BD is accurate and reliable.
Aripiprazole clearance in patients with BD is shown in Figure 3, where line a represents patients without receiving sodium valproate sustained-release tablets and line b represents those receiving sodium valproate sustained-release tablets. Under the same weight conditions, aripiprazole clearance increased by 66.7% in patients receiving sodium valproate sustained-release tablets. Figures 4 and 5 show the simulated aripiprazole concentrations in patients with BD who did not receive and those who received sodium valproate sustained-release tablets, respectively. Figures 6 and 7 show the probability of achieving concentrations within the therapeutic window in patients who did not receive and those who received sodium valproate sustained-release tablets, respectively. Furthermore, in patients with BD weighing 40-120 kg without receiving sodium valproate sustained-release tablets, the optimal initial dosage of aripiprazole was 0.3 mg/kg. In patients weighing 40-120 kg receiving sodium valproate sustained-release tablets, the optimal initial dosage of aripiprazole was 0.4 mg/kg, as shown in Table 4.
Figure 6 Probability within the therapeutic window range of aripiprazole in patients with bipolar disorder without receiving sodium valproate sustained-release tablets.
A: Patients with bipolar disorder without receiving sodium valproate sustained-release tablets were simulated to receive an aripiprazole dosage of (A) 0.1 mg/kg, (B) 0.2 mg/kg, (C) 0.3 mg/kg, (D) 0.4 mg/kg, (E) 0.5 mg/kg, (F) 0.6 mg/kg aripiprazole, (G) 0.7 mg/kg, and (H) 0.8 mg/kg.
Figure 7 Probability within the therapeutic window range of aripiprazole in patients receiving bipolar disorder with sodium valproate sustained-release tablets.
A: Patients with bipolar disorder receiving sodium valproate sustained-release tablets were simulated to receive an aripiprazole dosage of (A) 0.1 mg/kg, (B) 0.2 mg/kg, (C) 0.3 mg/kg, (D) 0.4 mg/kg, (E) 0.5 mg/kg, (F) 0.6 mg/kg aripiprazole, (G) 0.7 mg/kg, and (H) 0.8 mg/kg.
Table 4 Initial dosage recommendation of aripiprazole in patients with bipolar disorder.
Patients not receiving sodium valproate sustained-release tablets
In clinical practice, therapeutic drug monitoring (TDM) is used to adjust the dosage of aripiprazole to a certain extent[29-32]. The dosage is adjusted according to TDM results to meet individualized treatment needs. However, for the initial dosage, no TDM values are available as reference. Therefore, it is imperative to establish a precise initial dosing strategy for aripiprazole in patients with BD.
VCT is a research approach based on computer modeling and simulation, in which population pharmacokinetics is one of the principal methods and has been widely applied in studies of drug interactions and individualized dosing[33-37]. In this study, we analyzed concomitant medications, including atorvastatin calcium tablets, alprazolam tablets, ambroxol hydrochloride oral solution, benhexol hydrochloride tablets, clonazepam tablets, clozapine tablets, diazepam injection, escitalopram oxalate tablets, finasteride tablets, haloperidol injection, lamotrigine tablets, lithium carbonate extended-release tablets, lorazepam tablets, metformin hydrochloride tablets, olanzapine tablets, perphenazine tablets, propranolol hydrochloride tablets, quetiapine fumarate tablets, sertraline hydrochloride tablets, sodium valproate sustained-release tablets, zolpidem tartrate, and zopiclone tablets.
In the final aripiprazole model, weight and sodium valproate sustained-release tablets were identified as significant covariates. The CL/F and V/F of aripiprazole in patients with BD were 2.42 L/hour and 425 L, respectively. Under the same weight conditions, aripiprazole clearance rates in patients who did not receive and those who received sodium valproate sustained-release tablets were in a ratio of 1:1.667. Valproate is a widely used medication for treating epilepsy and BD, which exerts its effects by increasing the concentration of the inhibitory neurotransmitter gamma-aminobutyric acid in the brain, thereby reducing abnormal neuronal activity, controlling epileptic seizures, and stabilizing mood.
This finding that sodium valproat accelerates aripiprazole clearance is noteworthy. In patients with BD, concomitant use of sodium valproate sustained-release tablets significantly affects aripiprazole clearance, increasing the clearance rate by 66.7%. In other words, coadministration of sodium valproate accelerates the clearance of aripiprazole in patients with BD, suggesting that conventional dosing may be insufficient to achieve the desired therapeutic effect. This effect may be partly explained by the high plasma protein binding of both valproate and aripiprazole. When used together, competition for binding sites may increase the free fraction of aripiprazole, thereby increasing its clearance. Additionally, aripiprazole is mainly metabolized by CYP2D6 and CYP3A4 enzymes[21,22], and valproate can induce CYP3A4 activity[38]. This observation is consistent with previous reports. Eryilmaz et al[39] reported decreased aripiprazole concentrations following co-administration with valproate, which supports the findings of the present study.
Furthermore, since valproate accelerates the clearance of aripiprazole, the dosage of aripiprazole needs to be adjusted when valproate is used in combination. A VCT approach was used to simulate patients with BD weighing 40-120 kg. Simulated dosing regimens of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7 and 0.8 mg/kg aripiprazole were evaluated. The results showed that, in patients weighing 40-120 kg without receiving sodium valproate sustained-release tablets, the optimal initial dosage was 0.3 mg/kg aripiprazole. In patients weighing 40-120 kg receiving sodium valproate sustained-release tablets, the optimal initial dosage was 0.4 mg/kg aripiprazole.
This study has certain limitations. First, the data were derived from a single-center retrospective study with a limited sample size. Second, the nature and extent of the aripiprazole-valproate interaction may depend on treatment duration, which was not accounted for in the VCT simulations. Future studies should include prospective clinical trials with larger sample sizes and consideration of treatment duration.
CONCLUSION
To the best of our knowledge, this is the first study to explore DDI and initial dosage optimization of aripiprazole in patients with BD using a VCT approach. When sodium valproate sustained-release tablets are used in combination, the clearance of aripiprazole is increased, necessitating an increase in the dosage of aripiprazole in these patients.
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