Frontlight ResearchEarly access
Taking people in SpainPhase 3
Esketamine nasal spray compared with aripiprazole in older adults with hard-to-treat depression
Compares esketamine nasal spray with aripiprazole in older adults with depression.
Key facts
- Who runs it
- Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
- Where
- Barcelona, Granollers, Palencia, Pamplona, Sabadell, Barcelona, Sant Boi De Llobregat, and Sevilla, SpainSee the 11 sites
- Trial code
- Registry title
- Comparison of esketamine with an antidepressant versus aripiprazole with an antidepressant, in the refractory major depression disorder in elderly patients
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 220 people, planned
- Started
- 20 Feb 2026
- Expected to end
- 15 Jan 2029
- Type of study
- Interventional
- Record updated
- 30 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 60-74 years with depression that has not improved after several antidepressant treatments. It compares esketamine nasal spray with aripiprazole, each added to an antidepressant.
- Age
- 60-74 years
- Sex
- All sexes can join.
- Disease stage
- Current moderate to severe depressive episode that has not responded to treatment (refractory major depression disorder).
- Earlier treatment
- Must be taking an SSRI or SNRI antidepressant with less than 25% improvement after at least 6 weeks at an adequate dose, raised to the maximum allowed. Before that, 3 to 5 different antidepressants in total (including the current one) must have failed, each taken at an appropriate dose for at least 6 weeks, from at least 3 different classes of antidepressants. Must be taking a single oral antidepressant on day 1 before randomization.
Main reasons for not taking part
- Taking drugs that must not be combined with esketamine or aripiprazole
- High risk of suicide at the screening visit
- Taking part in another clinical trial with active treatment
- Cannot consent to join and has no representative to confirm taking part
- Allergy to any active ingredient or excipient of the treatments
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Patients between 60-74 years
- To be receiving antidepressant treatment that includes an an SSRI (Selective Serotonin Reuptake Inhibitors) /SNRI (Serotonin–norepinephrine reuptake inhibitors) at the time of screening that is not responding (less than 25% improvement in symptoms) after receiving an adequate dose [SmPC; 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
Who cannot take part
- 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
Where in Spain
- Fundació Hospitalàries BarcelonaBarcelona, SpainTaking people
- Fundació Hospitalàries Barcelona NordBarcelona, SpainTaking people
- Fundació Hospitalàries MartorellBarcelona, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Vall D'Hebrón HospitalBarcelona, SpainTaking people
- Fundació Hospitalàries Sant Boi_GranollersGranollers, SpainTaking people
- Centro Sociosanitario Hermanas Hospitalarias de PalenciaPalencia, SpainTaking people
- Clínica Psiquiátrica Padre MenniPamplona, SpainTaking people
- Corporacion Sanitaria Parc TauliSabadell, Barcelona, SpainTaking people
- Fundació Hospitalàries Sant BoiSant Boi De Llobregat, SpainTaking people
- Hospital Universitario Virgen del RocíoSevilla, SpainTaking people
About the trial
What the trial wants to find out
To evaluate the efficacy of esketamine nasal spray at flexible doses compared to aripiprazole at 8 weeks, both in combination with a continued antidepressant, in elderly participants (>60 years), who suffer from refractory major depression disorder (RMDD) with one episode current moderate to severe depressive disorder.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Comparison between esketamine nasal spray versus aripiprazole, both in combination with an antidepressant, in the refractory major depression disorder (RMDD) in elderly patients (CESAR)
- Plain-language title
- Esketamine nasal spray compared with aripiprazole in older adults with hard-to-treat depressionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 30 September 2026