Analysis of participants drop-out in antidepressant clinical trials and related influencing factors
10.11886/scjsws20210225002
- VernacularTitle:抗抑郁药临床试验受试者脱落情况及影响因素
- Author:
Xiaoqi ZHONG
1
;
Qinlin WANG
1
;
Huiwei LIANG
1
;
Xuan LI
1
;
Chanjuan YANG
1
Author Information
1. The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou 510370, China
- Publication Type:Journal Article
- Keywords:
Antidepressant;
Clinical trial;
Participant;
Drop-out;
Influencing factors
- From:
Sichuan Mental Health
2021;34(5):440-443
- CountryChina
- Language:Chinese
-
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.