University of Rennes, CHU Rennes, Inserm, Irset (Institut de recherche en santé, environnement et travail)-UMR_S 1085, CIC 1414 (Centre of Clinical Investigation of Rennes), Rennes, France
Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
BMJ Open. 2023 Aug 9;13(8):e062913. doi: 10.1136/bmjopen-2022-062913.
This descriptive study of registered trials aimed to identify large clinical trials on antidepressants for mental disorders: (1) to assess what proportion could be labelled as 'seeding trials' (trials for marketing purposes) and (2) to describe their methodological characteristics and outcomes.
A search was conducted across all trials registered on ClinicalTrials.gov by drug name in March 2017.
All trials registered in the database of ClinicalTrials.gov were screened. Large registered studies were received and studies focusing prospectively on the effects of antidepressants in mental health disorders. Specific data items were extracted automatically, and subsequently inspected, corrected and completed by hand.
Prospective studies were selected focusing on the effects of antidepressants in any mental health disorder with 800 participants or more planned for inclusion.
Three members from the study team independently assessed the following 'seeding trial' characteristics in each registered study: a high level of involvement of the product manufacturer in the study design, in the data analysis and reporting of the study, an abnormally low ratio of patient numbers to study site, spin and/or omissions of clinically relevant findings in the abstracts, and conclusions that focused on secondary endpoints and surrogate markers. Secondary outcomes were the exploration of a functional outcome and suicidality.
31 trials were identified from clinical trials database. 18/31 were published (58%). 8 of these 18 (44%) studies were identified as possible seeding trials. 13/31 (42%) large trials planned to explore functioning and 5/31 (16%) suicidality.
Large trials are rare in the field of antidepressant research. Some could be 'seeding trials'. Few explored suicidality. Identifying seeding trials from incomplete data entries in registries, especially when almost half of the studies were still unpublished, posed considerable challenges. The delay between our research and publication limits the strength of our conclusions.
CRD42017065591.
本研究对注册试验进行描述性分析，旨在确定针对精神障碍的抗抑郁药物的大型临床试验：（1）评估有多少比例可以被归类为“启动试验”（出于营销目的的试验）；（2）描述其方法学特征和结果。
2017 年 3 月，我们通过药物名称在 ClinicalTrials.gov 上对所有试验进行了搜索。
对 ClinicalTrials.gov 数据库中注册的所有试验进行了筛选。我们收到了大型注册研究，并对前瞻性关注抗抑郁药在精神健康障碍中影响的研究进行了筛选。自动提取特定的数据项，然后由人工进行检查、纠正和补充。
选择了计划纳入 800 名或以上参与者的针对任何精神健康障碍的抗抑郁药的前瞻性研究。
研究小组的 3 名成员独立评估了每个注册研究中的以下“启动试验”特征：产品制造商高度参与研究设计、数据分析和报告；患者数量与研究地点的比例异常低；摘要中遗漏或歪曲了临床相关发现；结论侧重于次要终点和替代标志物。次要结果是探索功能结局和自杀意念。
从临床试验数据库中确定了 31 项试验。其中 18 项（58%）已发表。这 18 项中有 8 项（44%）被认为是可能的启动试验。31 项大型试验中有 13 项（42%）计划探索功能，5 项（16%）探索自杀意念。
在抗抑郁药研究领域，大型试验很少。有些可能是“启动试验”。很少有试验探索自杀意念。从注册机构的不完整数据中识别启动试验，尤其是当近一半的研究仍未发表时，存在相当大的挑战。我们的研究和发表之间的时间延迟限制了我们结论的强度。
CRD42017065591。
