An Open-label Long-term Extension Safety Study of Intranasal Esketamine in Treatment-resistant Depression Save

Date Added
May 23rd, 2017
PRO Number
Pro00066401
Researcher
Robert Malcolm
Keywords
Depression, Drug Studies, Mental Health, Psychiatry
Summary

There is an ethical obligation to provide continued intranasal esketamine treatment to subjects who participated in select Phase 3 studies and for whom the benefit versus risk has been favorable. This study provides an opportunity for subjects who have participated in the ESKETINTRD3004 study to continue to receive open label intranasal esketamine until: it is commercially available or a pre-approval access program is made available to the subject in the subject?s respective country; the subject does not benefit from further treatment (based on the investigator?s clinical judgment), the subject withdraws consent; or the company terminates clinical development of intranasal esketamine for Treatment Resistant Depression (TRD).

Institution
MUSC
Recruitment Contact
Kristina Huebner
843-792-1231
huebnerk@musc.edu

ESKETINTRD3004: An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression Save

Date Added
January 26th, 2016
PRO Number
Pro00047444
Researcher
Robert Malcolm
Keywords
Depression, Drug Studies, Mental Health, Psychiatry
Summary

Major depressive disorder is a common, severe, chronic and often life-threatening illness. It is now the leading cause of disability worldwide. There is a clear need to develop novel and improved therapeutics for treatment-resistant major depression.

Studies with esketamine have shown robust antidepressant effects in several clinical studies and it has been well tolerated in these clinical studies.
The main purpose of this study is to assess the long-term safety, tolerability, and effectiveness of esketamine nasal spray plus a newly initiated oral (taken by mouth) antidepressant in patients with treatment-resistant depression.

All patients in this 60 week study will be treated with esketamine nasal spray plus a new oral anti-depressant. The new oral anti-depressant will be one of the following approved and marketed oral antidepressants: duloxetine (Cymbalta), escitalopram (Lexapro), sertraline (Zoloft), or venlafaxine extended release (Effexor XR).

Institution
MUSC
Recruitment Contact
Melissa Michel
843-792-1901
michelm@musc.edu

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