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

OBJECTIVE: To explore sex, racial and ethnic disparities in esketamine clinical trials for mental health disorders registered on ClinicalTrials.gov. METHODS: 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. RESULTS: = 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. CONCLUSIONS: 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.