Antipsychotic Withdrawal - Individual Patient Data Analysis of the Placebo Groups in Randomized Controlled Trials

背景：抗精神病药物用于治疗多种疾病。精神分裂症是主要的治疗适应症之一，但其他精神障碍，如双相情感障碍和破坏性行为障碍也是治疗抗精神病药物。抗精神病药物治疗的快速中止经常发生，例如由于副作用的发生或低依从性。戒断症状和复发是停用抗精神病药物的已知风险。在计划安全和成功的治疗时，避免停药、减量或转换抗精神病药物后的戒断症状和复发是一个关键因素。然而，有关抗精神病药物停药后的戒断症状的数据是稀缺的。目的：戒断症状和复发后停止antipsychotic treatment. Study Design：一个队列的4419例患者的数据检查45个随机对照试验（RCT）。
重要的是，本研究将不关注RCT中研究药物的影响。目前的分析集中在安慰剂组中停止研究前抗精神病药物治疗的患者。在这些患者中，将检查戒断症状和复发的频率、持续时间和严重程度。这些患者在接受安慰剂治疗前已停用研究前药物，将作为本分析的目标组。在接受安慰剂之前未服用研究前抗精神病药物的患者将作为对照组。基线是患者随机分配至安慰剂组后的首次临床评估，终点是基线后12周。本研究的数据由耶鲁大学数据开放获取（Yoda）提供。研究对象：精神分裂症、双相情感障碍、双相情感障碍和破坏性行为障碍儿童。
主要统计分析：使用广义线性混合模型（GLMM）检查安慰剂组中停用单个研究前抗精神病药物的患者（目标组）与安慰剂组中未使用单个研究前抗精神病药物的患者（对照组）的基线和终点。

Background: Antipsychotics are used in the treatment of several disorders. Schizophrenia is one of the main treatment indications, but other mental disorders, such as bipolar affective disorder and disruptive behavior disorders are also treated antipsychotics. Rapid discontinuation of treatment with antipsychotics occurs frequently, for example because of occurrence of side effects or low adherence. Withdrawal symptoms and relapse are among the known risks when discontinuing antipsychotics. Avoiding withdrawal symptoms and relapse after antipsychotic discontinuation, reduction, or switch is a key factor when planning a safe and successful therapy. However, data about withdrawal symptoms after antipsychotic discontinuation are scarce.Objective: Systematic examination of withdrawal symptoms and relapse after stopped antipsychotic treatment.
Study Design: Examination of a cohort of individual patient data of 4419 patients from 45 randomized controlled trials (RCTs). Importantly, this study will not focus on effects of the study medication of the RCTs. The present analysis focuses on patients in the placebo group who stopped their prestudy antipsychotic treatment. In these patients, frequency, duration, and severity of withdrawal symptoms and relapse will be examined. These patients, who have stopped their prestudy medication before receiving a placebo, will serve as a target group in the present analysis. Patients who have not been taking prestudy antipsychotics before receiving placebo will serve as a control group. Baseline is the first clinical assessment of the patient after randomized allocation to the placebo arm. Endpoint is 12 weeks after baseline. Data were made available for this study by Yale University Data Open Access (YODA). Participants: Schizophrenia, bipolar affective disorder, schizoaffective disorder, and children with disruptive behavior disorders.
Primary statistical analysis: Examination with a generalized linear mixed model (GLMM) of baseline and endpoint in patients in the placebo arm who stopped individual prestudy antipsychotics (target group) versus patients in the placebo arm without individual prestudy antipsychotics (control group).