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Personalized Escitalopram Dosing in Patients With Depression

NCT05210140 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2022-11-08

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 escitalopram for the depression treatment (10 mg/day)
2. Determine and quantify clinical benefits of personalized escitalopram dosing regimen based on the escitalopram blood level monitoring
3. Retrospectively estimate whether the information on CYP2C19 genotype is useful in the prediction of escitalopram blood level.

Conditions

  • Depressive Disorder, Major

Interventions

DRUG

Escitalopram

Escitalopram, a selective serotonin reuptake inhibitor (SSRI), is commercially known as ELORYQA®, Elicea®, Escital®,PRAMES® or Lata® in Serbia. The recommended dose for Major depressive disorder is 10mg/day. Based on the individual response, dose can be adjusted and the maximum dose is 20 mg/day; 5 mg/day dose is also available. Escitalopram is also indicated for treatment of Obsessive-compulsive disorder, Generalized anxiety disorder, Social anxiety disorder (Social phobia) and Panic disorder (with or without agoraphobia) by Medicines and Medical Devices Agency of Serbia. In known CYP2C19 poor metabolizers, initial dose should be 5mg/day during first 2 weeks, and based on the individual response it can be increased up to maximum of 10 mg of escitalopram per day, according to the guidelines of 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
2023-09-30
Completion
2023-11-30
FDA Drug
Yes

Countries

  • Serbia

Study Locations

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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 NCT05210140 on ClinicalTrials.gov