Addressing diversity gaps in esketamine clinical trials: a registry-based cross-sectional analysis of sex, race and ethnicity.
Damian Swieczkowski, Aleksander Kwaśny, Michal Pruc, Lukasz Szarpak, Wiesław Jerzy Cubała
International Journal of Psychiatry in Clinical Practice June 1, 2026 DOI: 10.1080/13651501.2026.2622532 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Registry-based cross-sectional analysis Peer reviewed |
|---|---|
| Sample size | 5,116 |
| Population | Participants in interventional esketamine trials with results posted on ClinicalTrials.gov |
| Topics | Depression Esketamine |
| Keywords | Clinical trial Ethnicity Race |
| Registration | NCT02493868 |
| Key findings | Esketamine clinical trials show significant racial and ethnic disparities, with underrepresentation of racial and ethnic minority groups. |
Abstract
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.
Comparable studies
Other cross-sectional and survey studies on esketamine for depression, most cited first.
Citations in the library
Cites 7
- Long-Term Safety and Maintenance of Response With Esketamine Nasal Spray in Participants With Treatment-Resistant Depression: Interim Results of the SUSTAIN-3 Study Neuropsychopharmacology May 12, 2023
- Esketamine Treatment for Depression in Adults: A PRISMA Systematic Review and Meta-Analysis. American Journal of Psychiatry March 1, 2025
- Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clinical Pharmacology & Therapeutics February 1, 2025
- Intraoperative Esketamine and Postpartum Depression Among Women With Cesarean Delivery: A Randomized Clinical Trial. JAMA Network Open February 3, 2025
- Exploring Esketamine's Therapeutic Outcomes as an FDA-Designated Breakthrough for Treatment-Resistant Depression and Major Depressive Disorder With Suicidal Intent: A Narrative Review. Cureus February 1, 2024
and 2 more in the library