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WITHDRAWN
NCT05210153

Personalized Sertraline Dosing in Patients With Depression

Sponsor: University of Belgrade

View on ClinicalTrials.gov

Summary

The aims of this study are to: 1. Determine the proportion of participants who are underdosed or overdosed under recommended dosing regimen of sertraline for the depression treatment (100 mg/day) 2. Determine and quantify clinical benefits of personalized sertraline dosing regimen based on the sertraline blood level monitoring 3. Retrospectively estimate whether the information on CYP2C19 genotype is useful in prediction of sertraline blood level.

Official title: Utility of Plasma Drug Level Monitoring and CYP2C19 Genotyping in Dose Personalization of Sertraline

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

0

Start Date

2020-07-16

Completion Date

2023-09-01

Last Updated

2026-05-15

Healthy Volunteers

Not specified

Interventions

DRUG

Sertraline

Drug: Sertraline, a selective serotonin reuptake inhibitor (SSRI), is commercially known as Sidata® or Zoloft® in Serbia. The recommended dose for Major depressive disorder is 100 mg/day. It is recommended to start therapy with 50 mg/day, and in the case of lack of therapeutic effect dose should be increased in 50 mg increments every 2 weeks until intended pharmacological effect is reached. Dose can be increased up to the maximum dose is 200 mg/day. Sertraline is also indicated for treatment of Obsessive-compulsive disorder, Generalized anxiety disorder, Social anxiety disorder (Social phobia), Panic disorder (with or without agoraphobia) and Post-traumatic Stress Disorder by Medicines and Medical Devices Agency of Serbia. Drug levels are expected to be 50% higher in CYP2C19 poor metabolizers as compared to normal metabolizers, but no specific dosing recommendations are given by the Medicines and Medical Devices Agency of Serbia.

Locations (3)

Clinical Centre of Serbia

Belgrade, Serbia

Institute of Mental Health

Belgrade, Serbia

Military Medical Academy

Belgrade, Serbia