Dataset from A Multi-centre, Randomised, Double-blind, Parallel Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release (Bupropion XL 300mg Once Daily), Escitalopram Oxalate (Escitalopram, 10mg-20mg Once Daily) in Subjects With Major Depressive Disorder

This multi-centre study will follow a randomised, double-blind, parallel-group, active-controlled design and will evaluate the efficacy, safety and tolerability of bupropion extended-release (XL) (300 mg/day) compared with escitalopram (10-20 mg/day) in outpatients and inpatients with major depressive disorder (MDD). The total duration of the study will be 11 weeks consisting of three phases. The screening phase (phase I) will be lasting for 0-14 days, subjects will be randomised to bupropion XL or escitalopram in a 1:1 ratio for acute phase treatment phase (phase II) for 8 weeks. There are 3 dose levels during this acute treatment phase. The 3-dose level plan is designed to ensure each drug is titrated according to the prescribing information and to reach an optimal clinical dose. Finally patients will enter the taper phase (phase III) for up to 1 week to assess and reduce the possible withdrawal symptoms. In China almost all existing antidepressants are available on the market, but bupropion XL has not yet been approved. This Phase III clinical trial will be used for the purpose of registering bupropion XL in China.

本项多中心临床试验采用随机、双盲、平行分组、阳性对照设计，旨在评估安非他酮缓释片（bupropion extended-release, XL，300mg/日）对比艾司西酞普兰（escitalopram，10-20mg/日）在重性抑郁障碍（major depressive disorder, MDD）门诊及住院患者中的疗效、安全性与耐受性。本研究总时长为11周，共分为三个阶段：筛选阶段（阶段I）时长为0至14天，受试者将以1:1的比例被随机分配至安非他酮XL组或艾司西酞普兰组，接受为期8周的急性期治疗（阶段II）。该急性期治疗阶段共设置3个剂量层级，旨在确保两种药物均能按照药品说明书的要求进行剂量滴定，并达到最优临床剂量。最后受试者将进入最长为期1周的减量阶段（阶段III），以评估并减轻可能出现的撤药症状。目前国内市场已上市几乎所有主流抗抑郁药物，但安非他酮XL尚未获得批准。本项Ⅲ期临床试验将用于安非他酮XL在华的注册申报。