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.