Analysis of participants drop-out in antidepressant clinical trials and related influencing factors / 四川精神卫生

ABSTRACT

ObjectiveTo analyze the drop-out rate of participants in antidepressant clinical trials and to explore the related influencing factors. MethodsA retrospective analysis was carried out on the participants of 9 antidepressant clinical trials conducted at the Affiliated Brain Hospital of Guangzhou Medical University from 2013 to 2020. A self-compiled questionnaire was used to collect the subjects' demographic data， disease characteristics and the final completion of the trial， thereafter， the participant drop-out rate and related influencing factors were discussed. ResultsA total of 157 cases were enrolled， including 120 cases completed and 37 cases dropped out the trail. The causes of drop-out were poor efficacy in 13 cases （35.14%）， presence of adverse reactions in 12 cases （32.43%）， withdrawal of informed consent in 8 cases （21.62%） and loss of follow-up in 4 cases （10.81%）. Correlation analysis showed that participant drop-out was positively correlated with the level of anxiety （r=0.224， P<0.01） and presence of adverse events （r=0.158， P<0.05）， meantime， negatively correlated with the level of education （r=-0.209， P<0.01） and overall efficacy （r=-0.545， P<0.01）. Binary Logistic regression analysis showed that education level （β=-0.611， OR=0.543， P<0.05）， number of visits （β=-1.831， OR=0.160， P<0.01） and overall efficacy （β=-2.286， OR=0.102， P<0.01） were the influencing factors of participant drop-out. ConclusionLow education level， first visit， poor outcome， high level of anxiety， and adverse events are the factors affecting participant drop-out in antidepressant clinical trials.