Esketamine nasal spray versus aripiprazole for hard-to-treat depression in older adults
Compares esketamine nasal spray with aripiprazole in older adults with resistant depression.
Plain-language title generated from the registry record
Registry title: Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients
Key facts
- Where
- Barcelona, Palencia, Pamplona, Sabadell, and Seville, SpainSee the 9 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 74 years old?
Source: NCT07153406, who can take part
Where in Spain
- Hospital Benito Menni y Fidmag Hermanas HospitalariasBarcelona, SpainNo longer taking part
- Hospital de la Santa Creu i Sant PauBarcelona, SpainNo longer taking part
- Hospital Mare de Déu de la MercèBarcelona, SpainNo longer taking part
- Hospital Sagrat Cor. MartorellBarcelona, SpainNo longer taking part
- Hospital Vall d'HebronBarcelona, SpainNo longer taking part
- Centro Sociosanitario Hermanas Hospitalarias de PalenciaPalencia, SpainNo longer taking part
- Clínica Psiquiátrica Padre MenniPamplona, SpainNo longer taking part
- Corporacion Sanitaria Parc TauliSabadell, SpainNo longer taking part
- Hospital Universitario Virgen del RocioSeville, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Trial code
- NCT07153406
- Record updated
- 4 September 2025
- Original description
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 depressiveRead full original descriptionShow less
Comparison of Esketamine Versus Aripiprazole,Both in Combination With a SSRI/SNRI(Selective Serotonin Reuptake Inhibitors/Serotonin and Norepinephrine Reuptake Inhibitors )in Treatment-resistant Major Depressive Disorder in Elderly Patients
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
Inclusion: 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: Treatment with drugs contraindicated with the use of esketamine and aripiprazole; 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 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; Patients in whom increased blood pressure or blood pressure intracranial fluid poses a serious risk.