4.5 Article

Therapeutic drug monitoring of sertraline in children and adolescents: A naturalistic study with insights into the clinical response and treatment of obsessive-compulsive disorder

Journal

COMPREHENSIVE PSYCHIATRY
Volume 115, Issue -, Pages -

Publisher

W B SAUNDERS CO-ELSEVIER INC
DOI: 10.1016/j.comppsych.2022.152301

Keywords

TDM; antidepressants; selective serotonin reuptake inhibitors; pharmacovigilance; steady state concentration

Categories

Funding

  1. German Federal Institute for Drugs and Medical Devices (BfArM) [V-15322/68605/2013-2018]
  2. German Federal Ministry of Education and Research [BMBF-FKZ: 001EZ0937]
  3. 'Verein zur Durchfuhrung Neurowissenschaftlicher Tagungen e.V.', Paulsborner Berlin

Ask authors/readers for more resources

This study examines the pharmacokinetics, pharmacodynamics, efficacy, and tolerability of sertraline in children and adolescents. The results show that dose and serum concentration have a significant impact on clinical efficacy, but not on side effects. Additionally, sertraline has good tolerability in children and adolescents. The study also reveals a diagnosis-specific effect between sertraline serum concentration and clinical efficacy for pediatric obsessive-compulsive disorder (OCD).
Background: Sertraline is a selective serotonin reuptake inhibitor with specific indications in child and adolescent psychiatry. Notwithstanding its frequent use and clinical benefits, the relationship between pharmacokinetics, pharmacodynamics, efficacy, and tolerability of sertraline across indications, particularly in non-adult patients, is not fully understood. Method: This naturalistic therapeutic drug monitoring (TDM) study was conducted in a transdiagnostic sample of children and adolescents treated with sertraline (n = 78; mean age, 14.22 +/- 2.39; range, 7-18 years) within the prospective multicenter TDM-VIGIL project. Associations between dose, serum concentration, and medication-specific therapeutic and side effects based on the Clinical Global Impression scale were examined. Tolerability was measured qualitatively with the 56-item Pediatric Adverse Event Rating Scale. Results: A strong linear positive dose-serum concentration relationship (with dose explaining 45% of the variance in concentration) and significant effects of weight and co-medication were found. Neither dose nor serum concentration were associated with side effects. An overall mild-to-moderate tolerability profile of sertraline was observed. In contrast with the transdiagnostic analysis that did not indicate an effect of concentration, when split into depression (MDD) and obsessive-compulsive disorder (OCD) diagnoses, the probability of clinical improvement significantly increased as both dose and concentration increased for OCD, but not for MDD. Conclusions: This TDM-flexible-dose study revealed a significant diagnosis-specific effect between sertraline serum concentration and clinical efficacy for pediatric OCD. While TDM already guides clinical decision-making regarding compliance, dose calibration, and drug-drug interactions, combining TDM with other methods, such as pharmacogenetics, may facilitate a personalized medicine approach in psychiatry.

Authors

I am an author on this paper
Click your name to claim this paper and add it to your profile.

Reviews

Primary Rating

4.5
Not enough ratings

Secondary Ratings

Novelty
-
Significance
-
Scientific rigor
-
Rate this paper

Recommended

No Data Available
No Data Available