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Blood Test-Guided dosing may boost depression treatment in kids and adults

NCT ID NCT07478796

Disease control Sponsor: Poznan University of Medical Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether measuring drug levels in the blood can help doctors give the right dose of antidepressants (sertraline, escitalopram, or fluoxetine) to hospitalized children and adults with major depression. About 180 participants will receive one of these medications, and their doses will be adjusted based on blood tests and symptom checks. The goal is to make treatment safer and more effective by personalizing dosing, especially for younger patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

depressive disorder major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression - major depressive disorder Depressive episodes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Szpital Kliniczny im. Karola Jonschera UMP (Poznan University of Medical Sciences)

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-572, Poland

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