Status:
NOT_YET_RECRUITING
Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Depressive Disorder
Eligibility:
All Genders
60-74 years
Phase:
PHASE3
Brief 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 participant...
Detailed Description
The study disease is resistant major depressive disorder, which has not responded to at least three different strategies with antidepressants, at least one of them being a combination or potentiation ...
Eligibility Criteria
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.
- 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
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2029
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT07153406
Start Date
September 15 2025
End Date
January 15 2029
Last Update
September 4 2025
Active Locations (9)
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1
Clínica Psiquiátrica Padre Menni
Pamplona, Navarre, Spain, 31014
2
Hospital Vall d'Hebron
Barcelona, Spain, 08014
3
Hospital De La Santa Creu i Sant Pau
Barcelona, Spain, 08041
4
Hospital Mare de Déu de La Mercè
Barcelona, Spain, 08042