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Not yet recruitingPhase 3

Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients

NCT07153406 · CESAR · Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Closed to entry
Status
Not accepting participants
Phase 3
Phase
220
Target enrolment
9
Study sites
Outside the US

What it is testing

Summary

Phase III, open label, randomised, multicentre, blind for evaluators clinical trial to evaluate the efficacy of esketamine nasal spray at flexible dosis compared to aripiprazole in elderly participants (\>60 years) who suffer from treatment-resistant major depressive

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Clinical response

    Measured over At week 8

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

60 Years to 74 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

9 study sites

FacilityCityRegionCountry
Clínica Psiquiátrica Padre MenniPamplonaNavarreSpain
Hospital Vall d'HebronBarcelonaSpain
Hospital De La Santa Creu i Sant PauBarcelonaSpain
Hospital Mare de Déu de La MercèBarcelonaSpain
Hospital Sagrat Cor. MartorellBarcelonaSpain
Hospital Benito Menni y Fidmag Hermanas HospitalariasBarcelonaSpain
Centro Sociosanitario Hermanas Hospitalarias de PalenciaPalenciaSpain
Corporacion Sanitaria Parc TauliSabadellSpain
Hospital Universitario Virgen del RocioSevilleSpain

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT07153406 on ClinicalTrials.gov →

Last updated in the registry 2025-09-04. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits