A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression

  • STATUS
    Not Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    1150
  • sponsor
    Janssen Research & Development, LLC
Updated on 2 June 2021
Investigator
The Medical Research Network, LLC
Primary Contact
Adams Clinical Trials, LLC (0.4 mi away) Contact
+526 other location
nasal spray
esketamine

Summary

The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).

Description

This is an open-label (the researchers and participants know the treatment the participant is receiving) long-term extension study. The study will consist of 2 open-label Phases: 4-week Induction phase (if applicable) and Open-Label Optimization/Maintenance phase (variable). Participants will enter the study Induction Phase from ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3005 (NCT02422186) and ESKETINTRD3006 (US sites only). Participants will enter the study Open-Label Optimization/Maintenance phase from ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868) (if appropriate at week 16) or ESKETINTRD3006 (US sites only). In the Open-Label Induction Phase, participants will self-administer flexibly-dosed esketamine nasal spray. During first 4 weeks in Optimization/Maintenance Phase responder participants from the induction phase of study 54135419TRD3008, will continue on the same dose of esketamine nasal spray from the induction phase and have a weekly intranasal treatment session frequency. Participants entering the optimization/maintenance phase from study ESKETINTRD3005 will also have a weekly intranasal treatment session frequency. However, as the ESKETINTRD3005 intranasal study medication is blinded at the time of entry into the current study, the dose of esketamine nasal spray will be administered as outlined in protocol. Participants entering the optimization/maintenance phase from study ESKETINTRD3003 (Direct Entry) or ESKETINTRD3004 who were ongoing in the Optimization, Maintenance, or Optimization/Maintenance phase, respectively, will have the option to have their current intranasal dosing frequency adjusted at the time of entry into 54135419TRD3008 study and should remain on the selected frequency from week 1 to week 4. A one-time dose change will be permitted at study entry. After 4 weeks, esketamine nasal spray treatment sessions will be individualized to either once weekly or once every other week at the fixed 2-week interval (based on clinical global impression - severity [CGI-S] performed at that visit), and every 4 weeks for participants dosed at the 4 week interval. Participants safety will be monitored throughout the study.

Details
Condition Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Treatment-Resistant
Treatment Intranasal Esketamine, Esketamine Nasal Spray
Clinical Study IdentifierNCT02782104
SponsorJanssen Research & Development, LLC
Last Modified on2 June 2021

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note