Department of Psychiatry, University Medical Center Utrecht Brain Center, Utrecht University, Utrecht, The Netherlands.
Corresponding author: Lyliana G. Nasib, PhD, University Medical Center Utrecht, Heidelberglaan 100, PO Box 85500, 3508 GA Utrecht (
J Clin Psychiatry. 2023 Mar 29;84(3):22m14531. doi: 10.4088/JCP.22m14531.
In the majority of randomized controlled trials (RCTs) conducted in schizophrenia populations, patients suffering from a substance use disorder (SUD) or suicidality are excluded. Excluding these patients from RCTs might impact the generalizability of results. The aim of this study is to determine whether excluding patients with suicidality and/or SUD impacts RCT results on symptomatic remission, premature study discontinuation, symptom severity, and social functioning. Across Europe and Israel, 481 patients with first-episode schizophrenia, schizophreniform disorder, or schizoaffective disorder, based on criteria, were recruited between May 26, 2011, and May 15, 2016, for the Optimization of Treatment and Management of Schizophrenia in Europe (OPTiMiSE) trial. Baseline characteristics and follow-up assessments were compared between patients with versus without baseline SUD and/or suicidality. A total of 446 patients met eligibility criteria for the OPTiMiSE trial and initiated amisulpride treatment, of whom 404 (91%) had data available on suicidality, SUD, duration of illness, and CDS score. Of the 360 eligible patients with baseline data on suicidality and SUD, 106 patients had comorbid suicidality and/or SUD while 254 patients had neither of these comorbidities. No significant differences in the likelihood to achieve symptomatic remission or to prematurely discontinue the study were found when comparing comorbid versus non-comorbid patients ( = .27). There were no significant differences in symptom severity and social functioning between the groups. Comorbid patients had a higher level of depressive symptoms and more impaired social functioning compared to non-comorbid patients. Excluding first-episode schizophrenia patients with comorbidities from clinical trials unlikely affects key outcome measures. It is recommended to include patients with comorbidities in clinical trials while carefully monitoring suicidality and implementing safety plans to gain insight into efficacy and safety of treatment in this substantial patient population. ClinicalTrials.gov identifier: NCT01248195.
在大多数针对精神分裂症患者进行的随机对照试验（RCT）中，患有物质使用障碍（SUD）或自杀意念的患者被排除在外。将这些患者排除在 RCT 之外可能会影响研究结果的普遍性。本研究旨在确定排除自杀意念和/或 SUD 的患者是否会影响 RCT 结果在症状缓解、提前研究终止、症状严重程度和社会功能方面的结果。在欧洲和以色列，根据标准，招募了 481 名首发精神分裂症、分裂情感障碍或分裂样障碍患者，这项研究招募工作于 2011 年 5 月 26 日至 2016 年 5 月 15 日进行，目的是在欧洲优化精神分裂症治疗和管理（OPTiMiSE）试验中。比较了基线有和没有基线 SUD 和/或自杀意念的患者的基线特征和随访评估。共有 446 名患者符合 OPTiMiSE 试验的入选标准，并开始接受氨磺必利治疗，其中 404 名（91%）患者有自杀意念、SUD、发病持续时间和 CDS 评分的数据。在 360 名有基线自杀意念和 SUD 数据的合格患者中，106 名患者同时存在共病自杀意念和/或 SUD，而 254 名患者则没有这些共病。与非共病患者相比，共病患者在达到症状缓解或提前终止研究的可能性上没有显著差异（ = .27）。两组在症状严重程度和社会功能方面没有显著差异。与非共病患者相比，共病患者的抑郁症状更严重，社会功能更受损。将伴有合并症的首发精神分裂症患者排除在临床试验之外不太可能影响关键的结局指标。建议将伴有合并症的患者纳入临床试验，同时仔细监测自杀意念，并制定安全计划，以深入了解治疗在这一大量患者群体中的疗效和安全性。临床Trials.gov 标识符：NCT01248195。
