Prajapati Asta R, Wilson Jonathan, Maidment Ian
Pharmacy Department, Norfolk and Suffolk NHS Foundation Trust, UK.
Department of Research, Norfolk and Suffolk NHS Foundation Trust, UK.
BMJ Open. 2016 Jan 6;6(1):e010237. doi: 10.1136/bmjopen-2015-010237.
Bipolar disorder requires long-term treatment but non-adherence is a common problem. Antipsychotic long-acting injections (LAIs) have been suggested to improve adherence but none are licensed in the UK for bipolar. However, the use of second-generation antipsychotics (SGA) LAIs in bipolar is not uncommon albeit there is a lack of systematic review in this area. This study aims to systematically review safety and efficacy of SGA LAIs in the maintenance treatment of bipolar disorder.
The protocol is based on Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) and will include only randomised controlled trials comparing SGA LAIs in bipolar. PubMed, EMBASE, CINAHL, Cochrane Library (CENTRAL), PsychINFO, LiLACS, http://www.clinicaltrials.gov will be searched, with no language restriction, from 2000 to January 2016 as first SGA LAIs came to the market after 2000. Manufacturers of SGA LAIs will also be contacted. Primary efficacy outcome is relapse rate or delayed time to relapse or reduction in hospitalisation and primary safety outcomes are drop-out rates, all-cause discontinuation and discontinuation due to adverse events. Qualitative reporting of evidence will be based on 21 items listed on standards for reporting qualitative research (SRQR) focusing on study quality (assessed using the Jadad score, allocation concealment and data analysis), risk of bias and effect size. Publication bias will be assessed using funnel plots. If sufficient data are available meta-analysis will be performed with primary effect size as relative risk presented with 95% CI. Sensitivity analysis, conditional on number of studies and sample size, will be carried out on manic versus depressive symptoms and monotherapy versus adjunctive therapy.
Ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication, conference presentation and the press.
PROSPERO CRD42015023948.
双相情感障碍需要长期治疗，但治疗依从性差是一个常见问题。抗精神病长效注射剂（LAIs）被认为可提高依从性，但在英国尚无用于双相情感障碍的许可药物。然而，第二代抗精神病药物（SGA）长效注射剂在双相情感障碍中的应用并不罕见，尽管该领域缺乏系统评价。本研究旨在系统评价SGA长效注射剂在双相情感障碍维持治疗中的安全性和有效性。
本方案基于系统评价与Meta分析的首选报告项目（PRISMA）制定，仅纳入比较双相情感障碍中SGA长效注射剂的随机对照试验。将检索PubMed、EMBASE、CINAHL、Cochrane图书馆（CENTRAL）、PsychINFO、拉丁美洲及加勒比卫生科学数据库（LiLACS）、http://www.clinicaltrials.gov，检索时间范围为2000年至2016年1月，检索无语言限制，因为第一代SGA长效注射剂于2000年后上市。还将联系SGA长效注射剂的制造商。主要疗效指标为复发率或复发延迟时间或住院次数减少，主要安全性指标为脱落率、全因停药率和因不良事件停药率。证据的定性报告将基于定性研究报告标准（SRQR）列出的21项内容，重点关注研究质量（使用 Jadad 评分、分配隐藏和数据分析进行评估）、偏倚风险和效应大小。将使用漏斗图评估发表偏倚。如果有足够的数据，将进行Meta分析，主要效应大小为相对风险，并给出95%可信区间。将根据研究数量和样本量对躁狂与抑郁症状以及单药治疗与辅助治疗进行敏感性分析。
由于不收集原始数据，无需伦理批准。研究结果将通过同行评审出版物、会议报告和新闻媒体进行传播。
PROSPERO CRD42015023948。
