A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression (SUSTAIN-3)

This open-label, long-term extension safety study (n=1146) of esketamine Nasal Spray (Spravato) in treatment-resistant depression (SUSTAIN-3) aims to assess the safety and tolerability of Spravato in participants with treatment-resistant depression (TRD).

Sponsored by Janssen Research & Development, LLC, the study comprises two open-label phases: a 4-week Induction phase and an Open-Label Optimization/Maintenance phase.

Participants will self-administer flexibly-dosed esketamine nasal spray during the Induction Phase and continue on the same dose during the Optimization/Maintenance Phase if they respond positively.

Safety will be monitored throughout the study, with participants from various locations in the United States and internationally involved. The study began in June 2016 and is expected to conclude in December 2022.

Topic Treatment-Resistant Depression Depression Safety
Compound Ketamine
Country United States of America Argentina Australia Austria Belgium Brazil Canada Czech Republic Finland France Germany Mexico Poland Spain Sweden Taiwan Turkey United Kingdom
Visit trial
Status Completed
Results Published Yes
Start date 09 June 2016
End date 30 December 2022
Phase Phase III
Design Open
Type Interventional
Generation Second
Participants 1146
Sex All
Age 18- 99
Therapy No

Trial Details

This study is an open-label, long-term extension study involving two phases: an Induction phase lasting 4 weeks and an Optimization/Maintenance phase with variable duration. Participants from several previous studies will enter either phase based on their previous involvement. During the Induction phase, participants will self-administer flexibly-dosed esketamine nasal spray. In the Optimization/Maintenance phase, participants will continue with the same dose of esketamine nasal spray from the Induction phase for the first 4 weeks, with treatment session frequency based on their response. After this period, treatment sessions will be adjusted to once weekly or once every other week based on clinical assessment. Participant safety will be closely monitored throughout the study.

Trial Number NCT02782104

Sponsors & Collaborators

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.

Papers

Safety and Efficacy with Esketamine in Treatment-Resistant Depression: Long-Term Extension Study
This Phase III open-label extension study (n=1148) evaluates the long-term safety and efficacy of esketamine nasal spray combined with oral antidepressants in treatment-resistant depression (TRD) patients who previously participated in other Phase III trials. The study involved flexible dosing of intranasal esketamine (twice-weekly during induction, then weekly to monthly during maintenance) with direct staff supervision, with participants either entering through a 4-week induction phase (n=458) or directly into maintenance (n=690) based on their previous response.

Data attribution

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