As interest has grown in the potential psychiatric applications of ketamine, the number of registered clinical trials has grown substantially. Herein, we summarize and analyze clinical trials registered with ClinicalTrials.gov that assess the treatment of any psychiatric disorder with ketamine or ketamine enantiomers (e.g., S-ketamine, R-ketamine), with a focus on ongoing clinical trials. A ClinicalTrials.gov search on February 21, 2020 returned 140 registered trials. Frequency data was analyzed to determine the distribution of study designs. The majority of trials (70%) investigated the therapeutic effect of ketamine in mood disorders (unipolar: 60%, bipolar: 0.7%, both: 5.7%). Suicidal ideation (13.1%), post-traumatic stress disorder (5.4%), and obsessive-compulsive disorder (3.6%) were also investigated. Intravenous (IV) administration was the most common route with 87% of the studies using IV ketamine. Single-dose studies represented 50% of IV ketamine studies. Few studies were assessing maintenance treatment. Most studies were phase I or II with few definitive phase III trials registered. Given the large number of ongoing studies assessing psychiatric application of ketamine, researchers and relevant stakeholders should consider not only completed, published studies, but also ongoing registered studies in adjudicating the most relevant research questions. More definitive phase III trials and maintenance studies of IV ketamine for mood disorders are required, as numerous completed and ongoing studies have already assessed and demonstrated the proof-of-concept of acute antidepressant effects in phase I and II trials.

中文翻译：

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注册的临床试验，研究氯胺酮治疗精神疾病的情况。

随着对氯胺酮潜在精神病学应用的兴趣增加，已注册的临床试验数量也大大增加。在此，我们总结并分析在ClinicalTrials.gov上注册的临床试验，该临床试验评估了使用氯胺酮或氯胺酮对映体（例如S-氯胺酮，R-氯胺酮）对任何精神疾病的治疗，重点是正在进行的临床试验。2020年2月21日在ClinicalTrials.gov上进行的搜索返回了140项注册试验。分析频率数据以确定研究设计的分布。大多数试验（70％）研究了氯胺酮对情绪障碍的治疗作用（单相：60％，双相：0.7％，两者：5.7％）。还调查了自杀意念（13.1％），创伤后应激障碍（5.4％）和强迫症（3.6％）。静脉（IV）给药是最常见的途径，其中有87％的研究使用IV氯胺酮。单剂量研究占静脉氯胺酮研究的50％。很少有研究评估维持治疗。大多数研究为I或II期，很少有确定的III期试验注册。鉴于有大量正在进行的评估氯胺酮在精神科应用的研究，研究人员和相关利益相关者不仅应考虑已完成的已发表研究，还应考虑正在进行的注册研究以裁定最相关的研究问题。由于许多已完成和正在进行的研究已经评估并证明了I和II期临床试验中急性抗抑郁作用的概念验证，因此需要更明确的III期临床试验和IV氯胺酮维持治疗研究。