Ethnoracial Inclusion in Clinical Trials of Ketamine in the Treatment of Mental Health Disorders

Black, Indigenous, and People of Color (BIPOC) are greatly underrepresented in ketamine clinical trials for mood disorders, despite experiencing high rates of such conditions. A review of double-blind, placebo-controlled, randomized ketamine trials from 1993 to 2020 found that among 380 participants, 73.7% were non-Hispanic White, 9.2% Black, 5.0% Hispanic/Latinx, and 0.8% Asian. Higher BIPOC inclusion was negatively correlated with the number of recruitment methods used. The lack of reported demographic information may further underestimate BIPOC participation. These disparities mean reported treatment outcomes may not generalize to all groups, and unequal access to novel treatments worsens health inequities.

Study at a glance

Abstract

OBJECTIVE: Despite strong evidence for the safety and efficacy of ketamine in the treatment of mood disorders, the enrollment of Black, Indigenous, and People of Color (BIPOC) has not been a focus of this research. Health disparities in the treatment of mood disorders in BIPOC indicate a strong need to understand the clinical, social, and pharmacological aspects of this novel treatment in people of color. METHOD: A comprehensive methodological search for double-blind, placebo-controlled, randomized ketamine clinical trials published from 1993 to 2020 was conducted across several databases to analyze the demographics of trial participants. Researchers contacted corresponding authors to obtain additional information. RESULTS: = 380 participants), 73.7% of the participants were non-Hispanic White, 9.2% were Black, 5.0% were Hispanic/Latinx, and 0.8% were Asian. Higher BIPOC inclusion was negatively correlated with the number of recruitment methods implemented across sites. The present study may underestimate the participation of BIPOC because of the lack of demographic information collected or published. CONCLUSIONS: BIPOC are greatly underrepresented in ketamine clinical trials despite high rates of mood disorders. Reported treatment outcomes may not generalize to all ethnic and cultural groups and significant disparities in access to such novel treatment paradigms exacerbate health disparities.