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

NCT07153406 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-09-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Benedicto Crespo Facorro, MD · Fundación para la Gestión de la Investigación en Salud de Sevilla

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-09-15
Completion
2029-01-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07153406 on ClinicalTrials.gov