An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives

The purpose of this expanded access program (EAP) is to provide expanded access to esketamine treatment and collect additional safety data and quality of life until esketamine is commercially available for participants with Treatment-Resistant Depression (TRD).

Topic Treatment-Resistant Depression
Compound Ketamine
Country Mexico
Visit trial
Status Recruiting
Results Published
Start date 08 September 2020
End date 30 October 2022
Chance of happening 100%
Phase Phase III
Design Open
Type Interventional
Generation First
Participants 37
Sex All
Age 18- 80
Therapy No

Trial Details

Participants will self-administer esketamine intranasally 56 milligram (mg) on Day 1 followed by 56 mg or 84 mg (as a flexible dose regimen) twice per week for 4 weeks. Participants greater than or equal to (>=) 65 years old will start at a dose of 28 mg on Day 1. Maintenance Phase: Participants will self-administer esketamine 56 mg or 84 mg intranasally once per week from Week 5 to Week 9. Subsequently from Week 9, based on the investigator's clinical judgment, participants will self-administer esketamine 56 mg or 84 mg intranasally once or twice a week.

NCT Number NCT04476446

Sponsors & Collaborators

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

Johnson & Johnson
One of the largest pharmaceutical companies in the world, Johnson & Johnson are responsible for bringing esketamine to market in the form of Spravato.

Data attribution

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