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Can esketamine help when other depression treatments fail? new study aims to find out.

NCT ID NCT07146503

Knowledge-focused Sponsor: Riccardo Guglielmo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study follows 100 adults with treatment-resistant depression who are prescribed esketamine nasal spray in real-world clinics. Researchers will track how well the drug works, who responds best, and how it affects daily life and thinking. The goal is to improve personalized care for people whose depression hasn't improved with standard treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Esketamine (nasal spray)
What this could lead to
If successful, this study could help doctors predict which patients with hard-to-treat depression will benefit most from esketamine, leading to more personalized treatment.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all patients, and esketamine can cause side effects like dizziness, nausea, and dissociation.

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 100 people

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

Started

Nov 2022

Expected to finish

Aug 2030

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

Outpatients

Ages

18 to 74 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 were: (a) age 18-74, (b) DSM-5 diagnosis of a major depressive episode (MDE), (c) failure to respond to at least 2 prior antidepressant treatments (ADTs), and (d) current treatment with an SSRI or SNRI for which esketamine nasal spray was deemed appropriate.

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Conditions

The condition(s) this trial relates to.

Anhedonia anxiety anxiety disorder cognitive disorder Depression depressive disorder Depressive Disorder, Treatment-Resistant Lethargy

As listed by the trial registrant

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

Anhedonia Anxiety APATHY Cognition Depression and quality of life Psychiatric comorbidities Temperament Treatment-resistant depression (TRD)

How to take part

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

  1. The places running it

    5 sites. 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

  • ASST Fatebenefratelli Sacco

    RECRUITING

    Milan, 20157, Italy

  • ASST Pavia

    RECRUITING

    Pavia, 27100, Italy

  • Csm Dds 8

    RECRUITING

    Genova, Ge, 16158, Italy

  • Ospedale Policlinico San Martino

    RECRUITING

    Genova, Ge, 16132, Italy

  • Università di Chieti

    RECRUITING

    Chieti, 66100, Italy

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