CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 183 enrolled
Drug / intervention
Esketamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04829318
NCT04829318Phase 4Completed
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Open-label Long-Term Extension Study for Participants With Treatment-Resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment From Study 54135419TRD3013

Janssen-Cilag Ltd.·interventional·Posted Apr 2, 2021·Updated Sep 18, 2025

In Brief

A Phase 4 clinical trial evaluating Esketamine and SSRI/SNRI for Depressive Disorder, Major. Completed, enrolled 183 participants across 59 sites in 14 countries.

Detailed Summary

The primary purpose of this study is to assess the long-term safety and tolerability of esketamine nasal spray in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in participants who have completed 32 weeks of esketamine nasal spray treatment in Study 54135419TRD3013 (NCT04338321).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder, Major
CountriesArgentina, Belgium, Bulgaria, Czechia, Finland, Germany, Greece, Hungary, Malaysia, Poland, South Africa, South Korea, Taiwan, Turkey (Türkiye)
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedApr 2, 2021
Enrollment StartApr 26, 2021
Primary CompletionJul 22, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.3 years ago

Interventions

Esketaminedrug

Esketamine will be self-administered as nasal spray.

SSRI/SNRIdrug

Participants will continue to take SSRI/SNRI that is approved for use in depression in their country of participation; off-label use of any SSRI/SNRI is not permitted. The continuing SSRI/SNRI dosage may be optimized throughout the study, at the investigator's discretion and based on the summary of product characteristics (SmPC) (or local equivalent, if applicable). During this LTE study, investigators will be allowed to switch individual participant's SSRI/SNRI for tolerability issues.