NCT07153406

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 60 Years – 74 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study disease is resistant major depressive disorder, which has not responded to at least three different strategies with antidepressants, at least one of them being a combination or potentiation strategy, with a current moderate-severe depressive episode. 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

• Depressive Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-09-15
• Completion: 2029-01-15
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

9 sites across 1 country: Spain