A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder

Brief summary

The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants who have treatment-resistant major depressive disorder (MDD) with a current moderate to severe depressive episode.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym

ESCAPE-TRD

status

COMPLETED

phase

PHASE3

study type

INTERVENTIONAL

enrollment

676

sponsor

Janssen-Cilag International NV

conditions

Depressive Disorder, Major

interventions

DRUG: Esketamine 28 mg; DRUG: Esketamine 56 mg; DRUG: Esketamine 84 mg; DRUG: Quetiapine XR 50 mg; DRUG: Quetiapine XR 100 mg; DRUG: Quetiapine XR 150 mg; DRUG: SSRI/SNRI

start date

2020-08-21

start date type

ACTUAL

primary completion date

2022-01-20

has results

true

data source

ClinicalTrials.gov

data processed

2026-10-29T09:00:05

modifications

selected fields only; whitespace normalized; brief summary truncated to 2,000 characters