Utility of Plasma Drug Level Monitoring and CYP2C19 Genotyping in Dose Personalization of Sertraline (PsyCise-S)

NCT05210153 WITHDRAWN

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.

Details

Lead sponsor	University of Belgrade
Status	WITHDRAWN
Start date	2020-07-16
Completion	2023-09-01

Conditions

• Depressive Disorder, Major

Interventions

• Sertraline

Primary outcomes

• Change from Baseline Depression severity score at week 8 — 8 Weeks
  Measured with clinician reported 21-item Hamilton rating scale for depression (HAM-D). Scale gives a score from 0 to 52 where higher score represents higher depression severity and worse outcome.
• Adverse drug reaction severity score at week 8 — 8 Weeks
  Measured with clinician reported UKU (Udvalg for Kliniske Undersogelser) side effect rating scale. Scale gives summary score from 0 to 3 where higher scores correspond to the greater side-effects severity and worse outcome.

Countries

Serbia