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.
ABSTRACT
<p><b>OBJECTIVE</b>To obtain peptide mimicking epitopes of Schistosoma japonicum (S. japonicum) through screening of a phage peptide library and to test their potential for induction of protection.</p><p><b>METHODS</b>S. japonicum infected sera from Microtus fortis (IMFS) and normal sera from Microtus fortis (NMFS) were used respectively to screen a 12-mers random peptide library by testing the reactivity of anti-S. japonicum serum with the phagotopes. After three rounds of biopanning, the pooled phages were used to immunize mice, after which challenge infection was performed.</p><p><b>RESULTS</b>Of 12 randomly picked clones, 10 clones selected using IMFS and 7 clones selected using NMFS were shown to be antigenic. Significant reduction in adult worms (22.6%) and a high reduction (68.9%) in liver eggs were achieved following immunization with phages screened with IMFS. However, no protection was elicited by those selected with NMFS.</p><p><b>CONCLUSION</b>The results show that the phagotopes are both antigenic and immunogenic, suggesting a potential use of phage displayed peptide as novel vaccines against S. japonicum.</p>