Therapeutic drug monitoring-guided SSRI dosing for hospitalized teens and adults
Therapeutic Drug Monitoring-Guided Treatment With Sertraline, or Escitalopram in Hospitalized Adults and Children
This project will test whether using blood-level monitoring (TDM) to guide dosing of fluoxetine, escitalopram, or sertraline helps hospitalized patients aged 12 and older with moderate to severe depression.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Poznan University of Medical Sciences Academic / other |
| Locations | 1 site (Poznan, Greater Poland Voivodeship) |
| Trial ID | NCT07478796 on ClinicalTrials.gov |
What this trial studies
This randomized, head-to-head trial compares fluoxetine, escitalopram, and sertraline in patients aged 12 and older using prospective therapeutic drug monitoring (TDM) across all arms. The protocol includes dense plasma sampling, pharmacogenetic profiling, and population PK/PD model development to characterize exposure-efficacy and exposure-safety relationships. Primary aims are to derive model-based therapeutic concentration ranges and practical individualized dosing recommendations; secondary analyses will compare effectiveness, tolerability, and time-to-response among the three agents. The study is conducted at Poznan University of Medical Sciences and focuses on hospitalized youth and young adults with moderate to severe depressive episodes.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients aged 12 or older with a moderate to severe depressive episode who require SSRI treatment and can provide informed consent (with guardian consent as needed).
Not a fit: People with other primary psychiatric disorders (such as bipolar disorder or schizophrenia), active pregnancy or breastfeeding, unstable severe medical conditions, or those already on an adequate SSRI dose are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide practical individualized dosing ranges and TDM guidance to improve SSRI effectiveness and reduce side effects in adolescents and young adults.
How similar studies have performed: Previous TDM and PK/PD studies in adults have suggested exposure-response relationships for some SSRIs, but randomized, pediatric-focused head-to-head trials that combine dense sampling and pharmacogenetics are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female gender. * Age 12 years or older. * Diagnosis of moderate or severe depressive episode requiring SSRI treatment (fluoxetine, escitalopram, or sertraline). * Written informed consent provided by patient and/or legal guardian. * Women of childbearing potential must agree to use effective contraception or sexual abstinence. Exclusion Criteria: * Pregnancy, breastfeeding, or planning pregnancy. * Diagnosis of other mental disorders (schizophrenia, bipolar disorder, intellectual disability). * Decompensated severe somatic disorders (e.g., endocrine disorders, asthma exacerbation, hepatic/renal failure). * Treatment with fluoxetine, sertraline, or escitalopram at an adequate dose for at least 4 weeks for the current episode (unless washout of 5x half-life is observed). * Use of medications with high risk of CYP enzyme interactions.
Where this trial is running
Poznan, Greater Poland Voivodeship
- Szpital Kliniczny im. Karola Jonschera UMP (Poznan University of Medical Sciences) — Poznan, Greater Poland Voivodeship, Poland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.