Therapeutic drug monitoring-guided SSRI dosing for hospitalized teens and adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Szpital Kliniczny im. Karola Jonschera UMP (Poznan University of Medical Sciences)
  Poznan, Greater Poland Voivodeship, Poland Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Step-by-step care plan to improve treatment for moderate depression in general practice

  It tests whether a structured step-by-step care plan used by general practitioners works better than usual GP care or psychologist-led behavioral therapy for adults 18–65 with moderate depression.

  Recruiting Aalborg University Hospital · Aalborg · NCT07263321

• Understanding how the orbitofrontal cortex guides approach vs. avoidance in depression

  This study tests how different parts of the orbitofrontal cortex influence whether people pursue rewards or risk loss, and whether this pattern is altered in Major Depressive Disorder.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07896343

• Health education program to help depression in older adults and caregivers in Ho Chi Minh City

  A community-based education program for people 60+ and their caregivers is being tested to see if it can lower depression and improve quality of life compared with standard care.

  Recruiting University of Medicine and Pharmacy at Ho Chi Minh City · Ho Chi Minh City, Cho Lon · NCT07877571

• Prucalopride for low mood: testing a 5-HT4 receptor activator for cognition and sleep

  This study tests whether prucalopride, a 5-HT4 receptor drug, can improve thinking and sleep in adults with low mood or major depressive disorder compared to a placebo.

  Recruiting University of Oxford · Oxford, Oxfordshire · NCT07848477

• Pre-visit Companion Brief: a primary care AI-assisted check for depression and anxiety

  This pilot tests an AI-powered pre-visit assessment that creates a concise Companion Brief for clinicians to help identify depression and anxiety during routine primary care.

  Recruiting Singula Health, Inc. · Brentwood, New York and 1 other locations · NCT07834684

• Medically tailored groceries to help depression in people with food insecurity

  This trial tests whether giving medically tailored groceries for six months can reduce depressive symptoms in adults who have depression and struggle with access to food.

  Recruiting at 2 sites University of Massachusetts, Worcester · Worcester, Massachusetts and 2 other locations · NCT07779707

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.