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Journal Article Ahead of print 1 citation

PubMed: 42484420 DOI: 10.1080/13651501.2026.2706177

Therapeutic drug monitoring of sertraline and symptom change in major depressive disorder: a naturalistic outpatient study.

Int J Psychiatry Clin Pract

Authors: Maria Luca, Alessandro Serretti, Antonina Luca, Filippo Drago, Ignazio Maniscalco, Xenia Hart, Georgios Schoretsanitis, Raffaele Ferri, Andreas Conca, Vincenzo Florio

Affiliations

  • Centre for Addiction, Adrano-Bronte, Italy.
  • Department of Medicine and Surgery, Kore University of Enna, Enna, Italy.
  • Oasi Research Institute-IRCCS, Troina, Italy.
  • Department of Biomedical and Biotechnological Sciences, Section of Pharmacology, University of Catania, Catania, Italy.
  • Department of Psychiatry, Libera Universita di Bolzano, Bolzano, Italy.
  • Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
  • Department of Molecular Neuroimaging, Central Institute of Mental Health, University of Heidelberg, Mannheim, Germany.
  • Unit of Pharmacogenetics and Clinical Psychopharmacology, Centre for Psychiatric Neuroscience, Lausanne University Hospital, University of Lausanne, Prilly, Switzerland. Department of Psychiatry, Northwell Health, The Zucker Hillside Hospital, Glen Oaks, NY, USA. Department of Adult Psychiatry and Psychotherapy, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.

Abstract

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.

MeSH

Serum, Pharmaceutical Preparations, Drug Monitoring, Depressive Disorder, Sertraline, Therapeutics, Outpatients, Depressive Disorder, Major