drugset / Trial / NCT07153406

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

NCT07153406

Phase 3 Not yet recruiting 220 enrolled Andalusian Public Foundation for Health Research in Seville
RandomizedParallel-groupSingle-blindTreatment

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

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aripiprazole Other / unclassified 5 mg Oral
Comparator Aripiprazole Other / unclassified 30 mg Oral
Subject Esketamine Other / unclassified 28 mg Intranasal
Subject Esketamine Other / unclassified 56 mg Intranasal
Subject Esketamine Other / unclassified 84 mg Intranasal

Indications