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Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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
Official title: Comparison of Esketamine Versus Aripiprazole,Both in Combination With a SSRI/SNRI(Selective Serotonin Reuptake Inhibitors/Serotonin and Norepinephrine Reuptake Inhibitors )in Treatment-resistant Major Depressive Disorder in Elderly Patients
Key Details
Gender
All
Age Range
60 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2025-09-15
Completion Date
2029-01-15
Last Updated
2025-09-04
Healthy Volunteers
No
Conditions
Interventions
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
Locations (9)
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