Location
Philadelphia, PA
Start Date
17-4-2026 1:30 PM
End Date
17-4-2026 2:30 PM
Description
Background: Major depressive disorder (MDD) affects approximately 21 million U.S. adults annually. Nearly 22% of individuals in the United States speak a language other than English at home. Language-based exclusion criteria in clinical trials may limit participation of non-English-speaking populations and reduce external validity in psychiatric research.
Objective: To evaluate the prevalence of English-language requirements in U.S.-based adult depression clinical trials and assess the availability of translation accommodations.
Methods: We conducted a cross-sectional review of U.S.-based interventional clinical trials listed on ClinicalTrials.gov. Adult (≥18 years) trials focused on major depressive disorder were included. Pediatric-only trials were excluded. Trials were assessed for explicit English-language requirements and documentation of translation services or interpreter accommodations. These findings were compared to overall U.S. interventional trials.
Results: Among U.S. interventional trials overall, 19% required English fluency for participation. In contrast, 52% of adult depression trials required English fluency, representing a 2.7-fold higher prevalence compared to general U.S. trials. Only 3% of trials reported offering formal translation services. The majority of trials did not specify whether interpreter assistance was permitted, and language criteria were frequently embedded within eligibility sections without justification.
Conclusion: English-language requirements are substantially more common in adult depression clinical trials compared to general U.S. trials, while translation services are rarely offered. These practices may contribute to underrepresentation of non-English-speaking populations in psychiatric research and limit generalizability of study findings. Increased transparency and standardized reporting of language inclusion criteria may improve equity in clinical research participation.
Embargo Period
6-3-2026
Included in
Language-Based Exclusion in Depression Clinical Trials: Implications for Generalizability
Philadelphia, PA
Background: Major depressive disorder (MDD) affects approximately 21 million U.S. adults annually. Nearly 22% of individuals in the United States speak a language other than English at home. Language-based exclusion criteria in clinical trials may limit participation of non-English-speaking populations and reduce external validity in psychiatric research.
Objective: To evaluate the prevalence of English-language requirements in U.S.-based adult depression clinical trials and assess the availability of translation accommodations.
Methods: We conducted a cross-sectional review of U.S.-based interventional clinical trials listed on ClinicalTrials.gov. Adult (≥18 years) trials focused on major depressive disorder were included. Pediatric-only trials were excluded. Trials were assessed for explicit English-language requirements and documentation of translation services or interpreter accommodations. These findings were compared to overall U.S. interventional trials.
Results: Among U.S. interventional trials overall, 19% required English fluency for participation. In contrast, 52% of adult depression trials required English fluency, representing a 2.7-fold higher prevalence compared to general U.S. trials. Only 3% of trials reported offering formal translation services. The majority of trials did not specify whether interpreter assistance was permitted, and language criteria were frequently embedded within eligibility sections without justification.
Conclusion: English-language requirements are substantially more common in adult depression clinical trials compared to general U.S. trials, while translation services are rarely offered. These practices may contribute to underrepresentation of non-English-speaking populations in psychiatric research and limit generalizability of study findings. Increased transparency and standardized reporting of language inclusion criteria may improve equity in clinical research participation.