MedTrace Logo

Personalized Sertraline Dosing in Patients With Depression

NCT05210153 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Depressive Disorder, Major

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.

Sponsors & Collaborators

  • Clinical Centre of Serbia

    collaborator OTHER

  • Institute of Mental Health, Serbia

    collaborator UNKNOWN

  • Military Medical Academy, Belgrade, Serbia

    collaborator OTHER

  • University of Belgrade

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-16
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Drug
Yes

Countries

  • Serbia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05210153 on ClinicalTrials.gov