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New hope for Hard-to-Treat depression in seniors: esketamine spray vs aripiprazole

NCT ID NCT07153406

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two add-on treatments—esketamine nasal spray and aripiprazole pills—for older adults (60-74) whose depression hasn't improved with standard antidepressants. Around 220 participants will receive either esketamine once or twice weekly or daily aripiprazole, alongside their current medication. The goal is to see which approach better reduces depressive symptoms and is safer over 32 weeks.

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 (flexible doses 28-84 mg) and oral aripiprazole (5-30 mg daily)
What this could lead to
If esketamine works better than aripiprazole, it could offer a new, fast-acting option for older adults with hard-to-treat depression.
What could go wrong
This is an early-phase 3 trial with no results yet. Esketamine may cause side effects like dizziness or dissociation, and the benefit over existing treatments is not guaranteed.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 220 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jan 2029

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

60 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: * Patients between 60-74 years * To be receiving antidepressant treatment that includes an antidepressant at the time of screening that is not responding (less than 25% improvement in symptoms) after receiving an adequate dose \[or local equivalent, if applicable\] for at least 6 weeks and have been increased to the dose maximum allowed * Current antidepressant treatment must have been immediately preceded by failure to respond to at least 3, but not more than 5, different consecutive treatments (all within the same moderately severe depressive episode) with antidepressant drugs (AD) taken at an appropriate dose for at least least 6 weeks (3 antidepressant failures including the current one) * To have been treated with at least 3 different classes of antidepressants between treatments taken at appropriate doses for at least 6 weeks without response in the current moderate to severe depressive episode (including current treatment with an antidepressant) * To be taking a single oral antidepressant on day 1 before randomization * Participants who, at the time of screening, are taking a combination of antidepressants and/or rescue treatment (other than aripiprazole) for the current moderate to severe depressive episode may participate in the study. Exclusion Criteria: * Treatment with drugs contraindicated with the use of esketamine and aripiprazole. * Patients in whom a high risk of suicide is detected at the screening visit, according to the criteria established by Columbia University according to the C-SSRS evaluation * Patients who are participating in another clinical trial with active treatment * Patients who do not have the capacity to consent to participation in the trial or who do not have a representative to confirm their participation * Hypersensitivity to any of the active ingredients of any of the branches of treatment, or to any of the excipients of its pharmaceutical form * Patients in whom increased blood pressure or blood pressure intracranial fluid poses a serious risk

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    9 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

  • Centro Sociosanitario Hermanas Hospitalarias de Palencia

    Palencia, 34004, Spain

  • Clínica Psiquiátrica Padre Menni

    Pamplona, Navarre, 31014, Spain

  • Corporacion Sanitaria Parc Tauli

    Sabadell, 08208, Spain

  • Hospital Benito Menni y Fidmag Hermanas Hospitalarias

    Barcelona, 08830, Spain

  • Hospital De La Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Hospital Mare de Déu de La Mercè

    Barcelona, 08042, Spain

  • Hospital Sagrat Cor. Martorell

    Barcelona, 08760, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08014, Spain

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