Introduction: ASPIRE-1 is one of two global phase-3 studies in the registration program to evaluate efficacy and safety of esketamine nasal spray (ESK) vs placebo, with comprehensive stan...
Objective: To assess the Patient Health Questionnaire (PHQ-9) as a predictor of relapse of depressive symptoms in treatment-resistant depression (TRD).
Introduction: Efficacy and safety of esketamine (ESK) nasal spray were evaluated in ASPIRE-2 (NCT03097133), one of two phase-3 studies in the first global registration program in an under...
Introduction: Meaningful change thresholds (MCT) derived from clinical outcome assessments quantify the change amount during pharmacologic treatment that is meaningful to the patient. We ...
Aim: Compare efficacy and safety of fixed doses of esketamine nasal spray plus oral antidepressant (AD) to oral AD plus placebo nasal spray for treatment-resistant depression (TRD).
Met...
Background: Numerous studies have demonstrated short-term efficacy of esketamine in treatment-resistant depression (TRD), whereas long-term antidepressant effects remain to be established...