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New treatment option for Depression - Major Depressive Disorder
Official title TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children
ClinicalTrials.gov ID: NCT07478796
What this study is testing
What is Fluoxetine?
Fluoxetine is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for depression - major depressive disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Use of medications with high risk of CYP enzyme interactions.
The study team makes the final eligibility decision.
Where it's taking place
- Poznan, Greater Poland Voivodeship, Poland
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poznan, Greater Poland Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.