Feasibility of a Noninterventional Decentralized Clinical Trial Model in Adults with Major Depressive Disorder

Objective: Adding to existing challenges in conducting clinical trials, COVID-19 has indefinitely affected modern clinical research. Decentralized clinical trials, using telemedicine and digital technology, may prove critical to the future of clinical development. This type of methodology in psychiatric trials remains largely unexplored; therefore, we evaluated the feasibility and quality of data collection in a randomized, sham-interventional trial using fully decentralized methodology in subjects with major depressive disorder (MDD). Methods: This was a four-week, noninterventional, two-cohort, decentralized, clinical trial. Eligible adults had a diagnosis of MDD and were medically stable. Subjects in cohort 1 continued stable antidepressant and antipsychotic treatment and were randomly assigned 1:1 into assisted or unassisted groups (ie, completing assessments at home aided by mobile healthcare providers or alone using study-provided materials, respectively). Subjects in cohort 2 continued stable antidepressant treatment only or with other therapy and could choose assignment to assisted or unassisted groups. Coprimary endpoints were operational effectiveness (assessed by completion rate, subject diversity, time to study start, and subject satisfaction) and data-collection integrity (assessed by subjects’ ability to collect assessments and real-time data availability). Safety analyses included incidence of adverse events and suicidality. Results: In cohort 1, 96 subjects were screened with 31 enrolled; in cohort 2, 46 subjects were screened with 26 enrolled. Most subjects (≥81% across study groups and cohorts), and more than 80% of both cohorts, completed all assessments. No major safety concerns were encountered. Conclusions: This study demonstrated that decentralized clinical trials can be performed in patients with stable MDD. Clinical trial registration number: None; this was a noninterventional trial.