Key Takeaways

From the Authors As published in the article
  1. Several racial and ethnic minority groups remain underrepresented in US antidepressant clinical trials.
  2. Female participants were considered overrepresented compared to the state-level benchmark but underrepresented compared to national antidepressant users.
  3. Differences in antidepressant pharmacokinetics, tolerability, and treatment response across demographic groups may not be fully captured when trial populations lack diversity.
  4. Targeted recruitment strategies and standardized demographic reporting may improve the applicability of antidepressant trial findings to real-world patient populations.
Extended Takeaways
  1. Demographic transparency remains a major limitation in the antidepressant trial literature: among 166 included US trials, sex was reported in 90.36%, but race in only 39.16% and ethnicity in 33.13%, which constrains subgroup interpretation even before representation is assessed.
  2. Using recruitment-region census data rather than national averages changes the benchmark for representativeness and may be more clinically relevant for US trial appraisal, especially when interpreting studies conducted in states with distinct racial and ethnic compositions.
  3. Not all racial groups were underrepresented to the same degree; White (73.10% vs 77.52%, P=.443), Black (20.21% vs 13.51%, P =.106), and NHPI (0.21% vs 0.16%, P=.069) enrollment did not differ significantly from state census benchmarks, so concerns about generalizability are driven by specific gaps rather than uniform underenrollment across all minority groups.
  4. Underrepresentation was concentrated in Asian, AIAN, multiracial, and Hispanic or Latino participants, with significant gaps for Asian (4.13% vs 5.67%, P<.001), AIAN (0.44% vs 0.89%, P<.001), multiracial participants (1.90% vs 2.26%, P=.031), and Hispanic or Latino participants (12.42% vs 17.20%, P <.001).
  5. The weighted average age was 46.04 years (CI: 44.67–47.60), so many trial samples may not reflect older adults who commonly receive antidepressants and may have different pharmacokinetic and tolerability profiles.
Read full article
Physicians Postgraduate Press, Inc. (PPP) makes no warranties about the accuracy or completeness of any information published in The Journal of Clinical Psychiatry or other PPP materials, and disclaims liability for any use or non-use of that information. Clinicians should not rely solely on these materials and should exercise their own professional judgment when making patient care decisions on an individualized basis.

Learn More About Psychedelics in Psychiatry

Explore the Collection
Neural network illustration symbolizing psychedelic research advancements

Subscribe to read
more articles

Subscribe