Addressing diversity gaps in esketamine clinical trials: a registry-based cross-sectional analysis of sex, race and ethnicity

To explore sex, racial and ethnic disparities in esketamine clinical trials for mental health disorders registered on ClinicalTrials.gov. We conducted a registry-based cross-sectional analysis of interventional esketamine trials with results posted on ClinicalTrials.gov (cut-off date: 10 February 2025). Using predefined eligibility criteria, two investigators independently extracted and verified trial-level data on sex, race, ethnicity and site locations as reported in the registry. Among 13 eligible trials (n = 5116), women constituted 62.9% of participants, while men comprised 37.1%. The racial distribution included White (69.08%), Asian (13.31%), Black or African American (3.60%), and American Indian or Alaska Native (0.08%). Native Hawaiian or Other Pacific Islander participants accounted for only 0.04%. Hispanic or Latino representation ranged from 10.57% to 11.02% due to discrepancies in results reporting in trial NCT02493868. Esketamine clinical trials demonstrate significant racial and ethnic disparities, with underrepresentation of racial and ethnic minority groups. Regulatory efforts to improve diversity must lead to more effective recruitment for fair representation in future research. Esketamine clinical trials show significant racial and ethnic disparities, with White participants making up 69.08% of the population.Asian participants accounted for 13.31%, while Black or African American participants represented only 3.60%, underscoring underrepresentation.American Indian or Alaska Native (0.08%) and Native Hawaiian or Other Pacific Islander (0.04%) groups were nearly absent from the analysed trials.Hispanic or Latino participants comprised 10.57–11.02% of trial populations, demonstrating variability in reporting and continued underrepresentation.Despite regulatory efforts to enhance diversity, trial enrolment strategies remain inadequate, emphasising the need for inclusive recruitment policies and geographically diverse site selection. Esketamine clinical trials show significant racial and ethnic disparities, with White participants making up 69.08% of the population. Asian participants accounted for 13.31%, while Black or African American participants represented only 3.60%, underscoring underrepresentation. American Indian or Alaska Native (0.08%) and Native Hawaiian or Other Pacific Islander (0.04%) groups were nearly absent from the analysed trials. Hispanic or Latino participants comprised 10.57–11.02% of trial populations, demonstrating variability in reporting and continued underrepresentation. Despite regulatory efforts to enhance diversity, trial enrolment strategies remain inadequate, emphasising the need for inclusive recruitment policies and geographically diverse site selection.本研究旨在探究ClinicalTrials.gov（ClinicalTrials.gov）平台注册的、用于治疗精神障碍的艾司氯胺酮（esketamine）临床试验中存在的性别、种族与民族差异。我们针对该平台上已公布结果的艾司氯胺酮干预类临床试验开展了基于登记库的横断面分析，数据截止日期为2025年2月10日。依据预先设定的纳入排除标准，两名研究者独立提取并验证了登记库中报告的试验层面数据，包括性别、种族、民族以及试验中心所在地信息。 在纳入分析的13项符合条件的试验（共5116名受试者）中，女性受试者占比62.9%，男性受试者占比37.1%。种族分布情况为：白人占69.08%、亚裔占13.31%、黑人或非裔美国人占3.60%、美国印第安人或阿拉斯加原住民占0.08%；夏威夷原住民或其他太平洋岛民受试者占比仅为0.04%。由于试验NCT02493868的结果报告存在差异，西班牙裔或拉丁裔受试者的占比区间为10.57%至11.02%。 艾司氯胺酮临床试验存在显著的种族与民族差异，少数种族与民族群体的入组代表性不足。具体而言，白人受试者占比达69.08%，亚裔占13.31%，黑人或非裔美国人仅占3.60%，凸显出少数群体代表性不足的问题；美国印第安人或阿拉斯加原住民（0.08%）与夏威夷原住民或其他太平洋岛民（0.04%）群体在试验中几乎未见入组。西班牙裔或拉丁裔受试者占比为10.57%~11.02%，既反映出结果报告的不一致性，也表明该群体仍存在入组不足的情况。尽管监管机构已采取措施提升试验多样性，但当前的受试者招募策略仍存在不足，这凸显出制定包容性招募政策、选择地理分布多样化的试验中心的必要性。