drugset
drugset / Trial / NCT03852160

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

NCT03852160 ↗

Phase 3 Withdrawn Janssen-Cilag International NV
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of treating participants with treatment-resistant depression (TRD) who have failed at least 2 (and no more than 6) prior antidepressant (AD) treatments in the current moderate to severe depressive episode with flexibly-dosed esketamine nasal spray plus a newly initiated oral standard-of-care AD compared with placebo nasal spray plus a newly-initiated standard-of-care oral AD, in achieving remission and staying relapse-free after remission.

Timeline

Start
2019-12-01
Primary completion
2021-07-25
Completion
2021-07-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 28 mg Intranasal
Subject Esketamine Other / unclassified 56 mg Intranasal
Subject Esketamine Other / unclassified 84 mg Intranasal
Background Agomelatine Small molecule 50 mg Oral
Background Bupropion Small molecule 300 mg Oral
Background Duloxetine Small molecule 120 mg Oral
Background Escitalopram Small molecule 10 mg Oral
Background Escitalopram Small molecule 20 mg Oral
Background Mirtazapine Other / unclassified 45 mg Oral
Background Sertraline Small molecule 200 mg Oral
Background Trazodone Prolonged Release Unknown 300 mg Oral
Background Trazodone Prolonged Release Unknown 450 mg Oral

Indications

major depressive disorder