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

This open-label long-term extension study (n=183), sponsored by Janssen-Cilag Ltd., aims to assess the safety and tolerability of esketamine nasal spray in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in participants with treatment-resistant major depressive disorder (TRD) who have completed 32 weeks of esketamine nasal spray treatment in a previous study.

The study involves participants who continue to receive esketamine nasal spray along with their current SSRI/SNRI medication. The duration of the study participation is 2 years or until esketamine is commercially available. The study started in April 2021 and is expected to complete in July 2024, with an estimated enrollment of 183 participants.

The primary outcome measures include assessing the percentage of participants with intervention-emergent adverse events, intervention-emergent adverse events of special interest, and suicidal ideation and behavior. Secondary outcome measures include assessing relapse rates and changes in depression severity scores. The study is being conducted across multiple locations globally.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country Argentina Belgium Czech Republic Finland Germany Poland Taiwan Turkey
Visit trial
Status Active, not recruiting
Results Published No
Start date 26 April 2021
End date 19 July 2024
Phase Phase IV
Design Open
Type Interventional
Generation Second
Participants 183
Sex All
Age 18- 74
Therapy No

Trial Details

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).

Trial Number NCT04829318

Sponsors & Collaborators

Janssen-Cilag
This company doesn't have a full profile yet, it is linked to a clinical trial.

Data attribution

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