A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression

The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral
antidepressant compared with an oral antidepressant (active comparator) plus intranasal
placebo in delaying relapse of depressive symptoms in participants with treatment-resistant
depression (TRD) who are in stable remission after an induction and optimization course of
intranasal esketamine plus an oral antidepressant.

本研究旨在评估鼻用艾司氯胺酮（intranasal esketamine）联合口服抗抑郁药，对比口服抗抑郁药（阳性对照active comparator）联合鼻用安慰剂（intranasal placebo），在延缓经鼻用艾司氯胺酮联合口服抗抑郁药诱导优化疗程后达到稳定缓解的难治性抑郁症（treatment-resistant depression, TRD）参与者的抑郁症状复发方面的疗效。