Experimental regimen: Esketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week
Control regimen: Oral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study
Study 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
Eligibility
Sex
ALL
Min age
60 Years
Max age
74 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Clinical response — At week 8 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)
Trial sites (9)
Facility
City
Region
Status
Clínica Psiquiátrica Padre Menni
Pamplona
Navarre
Hospital Vall d'Hebron
Barcelona
Spain
Hospital De La Santa Creu i Sant Pau
Barcelona
Spain
Hospital Mare de Déu de La Mercè
Barcelona
Spain
Hospital Sagrat Cor. Martorell
Barcelona
Spain
Hospital Benito Menni y Fidmag Hermanas Hospitalarias
Barcelona
Spain
Centro Sociosanitario Hermanas Hospitalarias de Palencia
Palencia
Spain
Corporacion Sanitaria Parc Tauli
Sabadell
Spain
Hospital Universitario Virgen del Rocio
Seville
Spain
More Fundación Pública Andaluza para la gestión de la Investigación en Sevilla trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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