International journal of psychiatry in clinical practice · 2026
Therapeutic drug monitoring of sertraline and symptom change in major depressive disorder: a naturalistic outpatient study.
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Luca Maria, Serretti Alessandro, Luca Antonina, Drago Filippo, Maniscalco Ignazio, Hart Xenia, Schoretsanitis Georgios, Ferri Raffaele, Conca Andreas, Florio Vincenzo
Аннотация
BACKGROUND: Therapeutic drug monitoring (TDM) has been proposed to address interindividual variability in antidepressant exposure and to support concentration-response informed dosing. However, evidence linking sertraline serum concentrations to clinical response remains inconsistent. This study examined whether steady-state serum concentrations of sertraline (SCS) are associated with symptom improvement in major depressive disorder (MDD).
METHODS: In this study, adult outpatients with MDD receiving sertraline monotherapy were assessed at baseline (t0), 1 month (t1) and 3 months (t2) using the 21-item Hamilton Depression Rating Scale (HAMD-21). Morning steady-state SCS were quantified by LC-MS/MS. Regression models tested associations between SCS and percentage symptom change (delta) at t1 and t2. An exploratory analysis evaluated the association between baseline HAMD-21 severity and delta at 3 months.
RESULTS: The sample included 52 patients. No association was observed between SCS and symptom change. In the exploratory analysis, baseline HAMD-21 scores were associated with delta at 3 months.
CONCLUSIONS: In our study, steady-state sertraline concentrations were not associated with symptom improvement over 3 months in linear models. Baseline symptom severity emerged as a key determinant of change, suggesting that limited baseline severity in part of the sample may have reduced sensitivity to detect concentration-response relationships.
METHODS: In this study, adult outpatients with MDD receiving sertraline monotherapy were assessed at baseline (t0), 1 month (t1) and 3 months (t2) using the 21-item Hamilton Depression Rating Scale (HAMD-21). Morning steady-state SCS were quantified by LC-MS/MS. Regression models tested associations between SCS and percentage symptom change (delta) at t1 and t2. An exploratory analysis evaluated the association between baseline HAMD-21 severity and delta at 3 months.
RESULTS: The sample included 52 patients. No association was observed between SCS and symptom change. In the exploratory analysis, baseline HAMD-21 scores were associated with delta at 3 months.
CONCLUSIONS: In our study, steady-state sertraline concentrations were not associated with symptom improvement over 3 months in linear models. Baseline symptom severity emerged as a key determinant of change, suggesting that limited baseline severity in part of the sample may have reduced sensitivity to detect concentration-response relationships.