NCT07153406View on ClinicalTrials.gov

Comparison of Esketamine Nasal Spray vs.Aripiprazole in Treat.Resistant Major Depressive Disorder in Elderly Patients

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

September 15, 2025

Primary Completion Date

September 15, 2026

Study Completion Date

January 15, 2029

Conditions
Depressive Disorder
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

Trial Locations (9)

31014

Clínica Psiquiátrica Padre Menni, Pamplona

34004

Centro Sociosanitario Hermanas Hospitalarias de Palencia, Palencia

41013

Hospital Universitario Virgen del Rocio, Seville

08014

Hospital Vall d'Hebron, Barcelona

08041

Hospital De La Santa Creu i Sant Pau, Barcelona

08042

Hospital Mare de Déu de La Mercè, Barcelona

08760

Hospital Sagrat Cor. Martorell, Barcelona

08830

Hospital Benito Menni y Fidmag Hermanas Hospitalarias, Barcelona

08208

Corporacion Sanitaria Parc Tauli, Sabadell

All Listed Sponsors
lead

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER