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
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)
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
Parallel
Experimental regimen
DrugEsketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week
Control regimen
DrugOral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study
Clinical response
Clinical response at week 8 after initiation of treatment, measured in terms of: * Remission of depressive symptoms; total score ≤10 on the MADRS (Montgomery-Asberg Depression Rating Scale )scale. * Adequate clinical response, if they show a reduction of ≥50% in the total score of the MADRS scale with respect to the initial score and a score ≤4 on the CGI severity scale. (Clinical Global Impression)
Safety profile of esketamine nasal spray and aripiprazole
Determination of the safety profile of esketamine nasal spray and aripiprazole in patients free of relapse at week 32, according to the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 throughout the study.
Clinical response
Clinical response measured in terms of: * Remission of depressive symptoms; total score ≤10 on the MADRS scale. * Adequate clinical response, if they show a reduction of ≥50% in the total score of the MADRS scale compared to the initial score and a score ≤4 on the CGI severity scale.
Safety profile of esketamine nasal spray and aripiprazole
Determination of the safety profile of esketamine nasal spray and aripiprazole at week 8, according to the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 throughout the study.
Free of relapse
Proportion of patients free of relapse at week 24 and week 32 in the group of patients with clinical remission at week 8.
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