Effect of different doses of agomelatine on liver function in patients with depressive disorders： a real-world study
10.11886/scjsws20250720001
- VernacularTitle:不同剂量阿戈美拉汀对抑郁障碍患者肝功能的影响：一项真实世界研究
- Author:
Jun LI
1
;
Shipan MIAO
1
;
Qianqian WANG
2
;
Suqi SONG
1
;
Xiaoping YUAN
1
;
Kai ZHANG
1
Author Information
1. Chaohu Hospital Affiliated to Anhui Medical University， Hefei 238000， China
2. School of Mental Health and Psychological Sciences， Anhui Medical University， Hefei 238000， China
- Publication Type:Journal Article
- Keywords:
Agomelatine;
Depressive disorder;
Liver function;
Dose effect;
Real-world study
- From:
Sichuan Mental Health
2025;38(6):486-490
- CountryChina
- Language:Chinese
-
Abstract:
BackgroundAgomelatine， a novel antidepressant with dual efficacy in mood improvement and sleep regulation， has been widely utilized in clinical treatment of depressive disorders. The association between agomelatine and hepatic dysfunction has garnered increasing attention， yet there remains limited research on its long-term effect of liver function in real clinical scenarios. ObjectiveTo investigate the effect of different doses of agomelatine on liver function in patients with depressive disorders in real clinical scenarios， and to ascertain its safety profile and efficacy differences. MethodsA retrospective study was conducted， enrolling 200 patients diagnosed with depressive disorders according to the International Classification of Diseases， tenth edition （ICD-10）， who received agomelatine treatment at the Department of Psychiatry of Chaohu Hospital Affiliated to Anhui Medical University from January 2019 to December 2024. Longitudinal follow-up was performed based on real-world data. Patients were divided into a low-dose group （25 mg/d） （n=121） and a high-dose group （50 mg/d） （n=79） based on their agomelatine dosage. Follow-up assessments were conducted at baseline， the 2nd， 6th， 14th， and 26th weeks after treatment initiation. Liver function indicators， including alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， and total bilirubin （TBIL）， were measured using a fully automated biochemical analyzer. Clinical symptoms were evaluated using the Hamilton Depression Scale-24 item （HAMD-24） and the Hamilton Anxiety Scale （HAMA）. ResultsNo statistically significant time effect， intergroup effect， or time-by-group interaction effect was observed for ALT， AST， or TBIL in either the low-dose or high-dose group （P>0.05）. The time effects for both HAMD-24 and HAMA scores in the two groups were statistically significant （Ftime=430.573， 395.737， P<0.01）. From the end of the 2nd week of treatment onward， the scores at each follow-up time point were significantly lower than those at the baseline period （P<0.01）. ConclusionBoth low-dose and high-dose agomelatine may have no significant effect on liver function in patients with depressive disorders， with no difference in liver function impairment was observed between dosage groups. Low-dose and high-dose agomelatine may be equally effective in alleviating depressive and anxiety symptoms in patients with depressive disorders. ［Funded by the Education Work Committee of the Anhui Provincial Committee for Outstanding Young Talents in Colleges and Universities （number， gxyqZD2022022）； the Key Project of Scientific Research Fund of Anhui Institute of Translational Medicine （number， 2023zhyx-B18）］
