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

Trial Details



Trial Number

Sponsors & Collaborators

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

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.