WithdrawnNot Applicable

Personalized Sertraline Dosing in Patients With Depression

Stopped: Due to slow rate of recruitment of patients with major depressive disorder in our site, it was not feasible to perform both planned Psycise studies. Therefore, all efforts were put into escitalopram study (Psycise-E).

Serbia0Started 2020-07-16

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosed Major Depressive Disorder * Starting monotherapy with sertraline * Signed written informed consent Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial has been withdrawn and is no longer recruiting, can you tell me if there are any similar studies on personalized sertraline dosing that I might be eligible for?
2This trial was looking at whether adjusting sertraline doses based on individual patient factors could improve depression outcomes after 8 weeks — is that kind of personalized dosing approach something you could already apply to my treatment outside of a trial?
3The study was specifically measuring both how well the treatment worked and how severe any side effects were at 8 weeks — how do you currently monitor and adjust sertraline dosing for patients like me to balance those same concerns?
4Given that this trial was listed as 'Phase NA,' which sometimes applies to studies focused on dosing strategies rather than testing a brand-new drug, would standard sertraline treatment be a reasonable option for me to consider right now while I look into other research opportunities?
5Are there other active clinical trials studying optimized or personalized antidepressant dosing for major depressive disorder that my care team could help me explore as an alternative to this withdrawn study?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline Depression severity score at week 8

Timeframe: 8 Weeks

Adverse drug reaction severity score at week 8

Timeframe: 8 Weeks

Trial details

NCT IDNCT05210153

SponsorUniversity of Belgrade

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-01

View on ClinicalTrials.gov More Depressive Disorder, Major trials