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NOT YET RECRUITING
NCT07153406
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Experimental regimen

Esketamine intranasal spray at flexible doses (28, 56 and 84 mg) once or twice a week

DRUG

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