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

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

CONDITION

Mental Health

GENDER

Both males and females

AGE GROUP

18 years and above

TRIAL STATUS

Completed

This is a Phase 3, multi centre, open label, long term (up to 52 weeks) study of the safety and efficacy of esketamine administered by nasal spray in treatment resistant depression. Study participants will also be taking one of four oral antidepressant medications as background therapy.

Major depressive disorder (MDD) is a serious, recurrent, and disabling psychiatric illness. It is the second leading cause of years lost to disability worldwide and is associated with excess mortality, and the estimated median years of potential life lost is 10 years. About 30% of patients fail to achieve remission despite treatment with multiple antidepressant medications, and are considered to have treatment resistant. depression (TRD).

There is a significant need to develop novel treatments based upon relevant pathophysiologic pathways underlying MDD for the rapid relief of symptoms of depression, especially in patients with TRD.

 

CONTACT DETAILS

Phone Number: 08 8182 9554
Email: beverley.hisee@sa.gov.au
Location: Elizabeth Vale, South Australia, Australia

CONTACT SITE

Approved By: The Alfred Hospital Ethics Committee Victoria              

Clinical Trial Registry Link: