Status:
UNKNOWN
Personalized Sertraline Dosing in Patients With Depression
Lead Sponsor:
University of Belgrade
Collaborating Sponsors:
Clinical Centre of Serbia
Institute of Mental Health, Serbia
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-60 years
Brief 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. ...
Detailed Description
Sertraline is an antidepressant extensively metabolized by the polymorphic CYP2C19 enzyme. Based on CYP2C19 genotype, patients can be classified as: * Normal metabolizers (Normal CYP2C19 enzyme capac...
Eligibility Criteria
Inclusion
- Diagnosed Major Depressive Disorder
- Starting monotherapy with sertraline
- Signed written informed consent
Exclusion
- Patient's requests to leave the study
- Patients who had taken sertraline before
- Dementia
- Severe liver function impairment (abnormal AST/ALT ratio)
- Severe kidney function impairment (abnormal creatinine clearance)
- History of drug addiction (sporadic use is permitted)
- Suicide risk
- Patients who are taking strong CYP2C19 inhibitors
- Severe adverse drug reaction
Key Trial Info
Start Date :
July 16 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT05210153
Start Date
July 16 2020
End Date
November 1 2023
Last Update
November 8 2022
Active Locations (3)
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1
Clinical Centre of Serbia
Belgrade, Serbia, 11000
2
Institute of Mental Health
Belgrade, Serbia, 11000
3
Military Medical Academy
Belgrade, Serbia, 11000