Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients
NCT ID: NCT07153406
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
220 participants
INTERVENTIONAL
2025-09-15
2029-01-15
Brief Summary
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Detailed Description
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The aim of the study is to evaluate the efficacy of esketamine nasal spray at flexible dosis compared to aripiprazole at 8 weeks, both in combination with a continued antidepressant, in elderly participants (\>60 years), who suffer from treatment-resistant major depressive disorder with one episode current moderate to severe depressive disorder
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Esketamine
Esketamine intranasal spray at flexible doses 28, 56 and 84 mg once or twice a week
Experimental regimen
Esketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week
aripiprazole
Oral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study
Control regimen
Oral aripiprazole 5-30 mg daily, once or twice daily for the duration of the study
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
74 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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Benedicto Crespo Facorro, MD
Role: PRINCIPAL_INVESTIGATOR
Fundación para la Gestión de la Investigación en Salud de Sevilla
Locations
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Clínica Psiquiátrica Padre Menni
Pamplona, Navarre, Spain
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CESAR
Identifier Type: -
Identifier Source: org_study_id
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