Objective To investigate participant dropout in anti-depressant clinical trials and explore influencing factors. Methods Data from 9 clinical trials for anti-depressants from 2013 to 2020 conducted in The Affiliated Brain Hospital of Guangzhou Medical University, including patient demographics, disease characteristics, trial completion, and so on, were retrospectively analyzed. SPSS 22.0 package was used to investigate participant dropout and explore influencing factors. Results Among 194 identified participants, 157 were eventually enrolled; 37 were dropout cases. Reasons for dropout included poor therapeutic effect in 13 cases (35.14%), the presence of adverse events in 12 cases (32.43%), withdrawal of informed consent in 8 cases (21.62%), and loss to follow up in 4 cases (10.81%). Correlation analysis found that trial dropout was correlated positively with the level of anxiety (r=0.224, P<0.01) and the presence of adverse events (r=0.158,P<0.05), and negatively with the level of education (r=-0.209, P<0.01), overall therapeutic effect (r=-0.545, P<0.01). Binary logistic regression analysis showed that level of education (β=-0.611, OR=0.543, P<0.05), number of visits (β=-1.831, OR=0.160, P<0.01), and overall therapeutic effect (β=-2.286,OR=0.102, P<0.01) were influencing factors for trial dropout. Conclusion Increased dropout rates were associated with lower level of education, first medical contact, poor overall therapeutic effect, higher level of anxiety and the presence of adverse effect. |