Liu Yiyun, Zhou Xinyu, Qin Bin, Del Giovane Cinzia, Zhang Yuqing, Xie Peng
Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, 1 Yixueyuan Road, Yuzhong District, Chongqing 400016, China.
Syst Rev. 2014 Nov 5;3:133. doi: 10.1186/2046-4053-3-133.
Major depressive disorder (MDD) is a debilitating and costly mental disorder. Although commercially available antidepressants have proliferated over the last 20 years, a substantial number of patients either do not respond adequately to these drugs or are unable to tolerate their adverse effects. One common approach has been to augment conventional antidepressants with an adjunctive agent, but the optimal selection of atypical antipsychotic agents for adjunctive treatment of treatment-resistant depression (TRD) remains controversial.
METHODS/DESIGN: An electronic literature search of PubMed, the Cochrane Library, Embase, Web of Science, LiLACS, CINAHL, and PsycINFO for studies will be conducted with no restrictions on language, publication year, or publication type. Several clinical trial registry agencies, pharmaceutical company websites, and FDA reports will also be reviewed. Randomized clinical trials (RCTs) with atypical antipsychotic augmentation treatment for treatment-resistant depression will be considered. Data will be independently extracted by two reviewers. Traditional pairwise meta-analyses will be performed for RCTs that directly compare different treatment arms. Then, Bayesian network meta-analyses will be performed to compare the relative efficacy and acceptability of different atypical antipsychotic agents (and doses). A sensitivity analysis will be performed by excluding studies classified as a small sample size, having a high placebo effect.
This systematic review and network meta-analysis will comparatively analyze the efficacy, quality of life, and acceptability profiles of atypical antipsychotic medications used for the adjunctive treatment of TRD. The findings should provide clinically relevant implications for comprehensively understanding the risk-benefit profiles of these adjunctive treatments.
PROSPERO CRD 42014009666.
重度抑郁症(MDD)是一种使人衰弱且代价高昂的精神障碍。尽管在过去20年里,市面上可买到的抗抑郁药激增,但仍有相当数量的患者对这些药物反应不佳或无法耐受其副作用。一种常见的方法是用辅助药物增强传统抗抑郁药的疗效,但用于难治性抑郁症(TRD)辅助治疗的非典型抗精神病药物的最佳选择仍存在争议。
方法/设计:将对PubMed、Cochrane图书馆、Embase、科学网、拉丁美洲及加勒比地区卫生科学数据库、护理学与健康领域数据库以及心理学文摘数据库进行电子文献检索,对语言、出版年份或出版类型不设限制。还将查阅几个临床试验注册机构、制药公司网站和美国食品药品监督管理局的报告。将纳入非典型抗精神病药物增强治疗难治性抑郁症的随机临床试验(RCT)。数据将由两名审阅者独立提取。将对直接比较不同治疗组的RCT进行传统的成对荟萃分析。然后,将进行贝叶斯网络荟萃分析,以比较不同非典型抗精神病药物(及剂量)的相对疗效和可接受性。将通过排除分类为小样本量、安慰剂效应高的研究进行敏感性分析。
本系统评价和网络荟萃分析将比较分析用于TRD辅助治疗的非典型抗精神病药物的疗效、生活质量和可接受性概况。研究结果应为全面了解这些辅助治疗的风险效益概况提供临床相关启示。
国际前瞻性系统评价注册库CRD 42014009666。