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TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children

RecruitingPhase 4Ages 12 Years - anyAllPoznan University of Medical Sciences
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In plain words

What the trial is, and whether it could suit you

Depression in childhood and adolescence is a serious and increasing public-health problem associated with profound short- and long-term consequences, including impaired social and educational functioning, increased risk of somatic illness and substance use, and elevated mortality from suicide. Up to half of depressive disorders beginning in youth persist into adulthood, and the COVID-19 pandemic, with its attendant social isolation, has further increased the incidence of clinically significant depressive illness in children and young adults. Despite the high burden of disease, pharmacotherapeutic guidance for pediatric depression remains limited. Selective serotonin reuptake inhibitors (SSRIs) are first-line agents, yet dosing recommendations for youth do not adequately account for major sources of variability such as developmental pharmacokinetics, body size, age, comorbid diagnoses, an

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Fluoxetine
  • Escitalopram
  • Sertralin
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Where

1 site
Szpital Kliniczny im. Karola Jonschera UMP (Poznan University of Medical Sciences)
Poznan, Poland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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