NCT04829318

A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Janssen-Cilag Ltd. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	Esketamine	Esketamine will be self-administered as nasal spray.
DRUG	SSRI/SNRI	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.

Timeline

• Start date: 2021-04-26
• Primary completion: 2024-07-22
• Completion: 2024-07-22
• First posted: 2021-04-02
• Last updated: 2025-09-18
• Results posted: 2025-09-18

Locations

59 sites across 14 countries: Argentina, Belgium, Bulgaria, Czechia, Finland, Germany, Greece, Hungary, Malaysia, Poland, South Africa, South Korea, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study