Comparison of Esketamine Nasal Spray and Placebo in Adults with Treatment-Resistant Major Depressive Disorder

What this Trial Is About

Researchers are evaluating the effects of different doses of esketamine nasal spray compared with a placebo in adults with treatment-resistant depression. This study focuses on individuals diagnosed with major depressive disorder MDD who have not responded to at least two adequate antidepressant treatments during their current depressive episode. The goal is to see how well esketamine can improve depressive symptoms in this group. Participants will be randomly assigned to receive either 56 mg or 84 mg of esketamine nasal spray or a placebo spray twice a week for four weeks during the double-blind phase. Those who complete this phase may join an open-label phase lasting up to 12 weeks, where they will receive either 56 mg or 84 mg of esketamine. The nasal spray is self-administered by the participants under study conditions. During the study, participants will be assessed regularly with depression rating scales such as the Montgomery-Asberg Depression Rating Scale MADRS and the Patient Health Questionnaire 9-item PHQ-9. These assessments will track changes in depressive symptoms, including anhedonia and overall severity. Safety and response to treatment will be monitored throughout the double-blind and open-label phases, lasting a total of up to 16 weeks from the start of treatment.

A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression