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AI tool aims to end guesswork in depression treatment

NCT ID NCT06550037

Knowledge-focused Sponsor: Alessio Fasano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is collecting data from 350 people with major depression to build an AI tool that helps doctors choose the best antidepressant for each patient. Researchers are analyzing blood, gut bacteria, brain activity, and genetics to find patterns that predict treatment success. The goal is to make depression care more personalized and effective.

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.

Participants

About 350 people

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

Started

Aug 2023

Expected to finish

May 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.

Who is studied

Patients with Major Depressive Disorders

Ages

14 to 50 years

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: * Patients diagnosed with Major Depressive Disorder as certified by a SCID 5 (Structured Clinical Interview for DSM-5) for DSM-S for adults and K-SADS-PL-DSM 5 (Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime for DSM 5) for adolescents. * Currently experiencing a major depressive episode with a HAM-D (Hamilton Depression) score of 18 or greater, or alternatively, a MADRS (Montgomery-Asberg Depression Rating Scale) score of 18 or greater. * About to start a new antidepressant. * Not concurrently starting a new psychotropic medication. * Age 14-50 years. * Able to use mobile devices (smart phone, tablet). * Willingness to provide written informed consent to participate. Exclusion Criteria: * Intellectual disability. * Neurological disease (multiple sclerosis, severe neurocognitive disorder, epilepsy). * Current psychotic disorder or mood disorder with psychotic features. * Primary diagnosis of alcohol or substance use disorder (DSM-5). * Patients who started concomitant psychotropic medications less than one week ago. * Active, ongoing inflammatory diseases (such as rheumatoid arthritis and rheumatic polymyalgia). or severe and unstable physical illness (such as recent myocardial infarction). * A history of hepatitis B or C, human immunodeficiency virus, or evidence of active tuberculosis infection or any active systemic infection within 2 weeks prior to the start of the study. * Use of antibiotics or other medications that may have affected the composition of the microbiota during the 30 days prior to baseline. * Pregnancy and lactation.

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Conditions

The condition(s) this trial relates to.

Inflammation major depressive disorder

As listed by the trial registrant

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

Major depressive disorder

Contacts and locations

Locations

  • Università Degli Studi Di Siena

    Siena, 53100, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.