Psychological Status of Volunteers in a Phase I Clinical Trial Assessed by Symptom Checklist 90 (SCL-90) and Eysenck Personality Questionnaire (EPQ)
Yudong Wei, Haiyan Li, Huali Wang, Shuang Zhang, Yumei Sun
(Drug Clinical Trial Center, Peking University Third Hospital, Beijing, China (mainland))
Med Sci Monit 2018; 24:4968-4973
The psychological status of volunteers was investigated to provide a theoretical method for Phase I clinical trial management and result analysis.
MATERIAL AND METHODS: The Symptom Checklist 90 (SCL-90) and Eysenck Personality Questionnaire (EPQ) were used to assess the psychological status 200 healthy Chinese volunteers.
RESULTS: SCL-90 results indicate that the average value of positive factors is 10.32±14.26 by self-assessment of healthy volunteers, somatization factor is 1.13±0.13, compulsive symptom factor is 1.29±0.27, interpersonal sensitivity factor is 1.31±0.21, depression factor is 1.26±0.33, anxiety factor is 1.21±0.21, hostility factor is 1.08±0.26, phobia factor is 1.05±0.18, paranoid factor is 1.12±0.23, and psychotic symptom factor is 1.17±0.26.
CONCLUSIONS: Compared to the norm in China, the score of each factor of healthy volunteers was relatively low, with a statistically significant difference (P<0.001). EPQ results show that P score was 4.59±2.33, E score is 13.13±4.32, N score was 6.89±5.26, and L score was 13.21±4.25 for the 200 healthy volunteers. Compared to the norm in China, the P and N scores were lower, and the E and L scores were higher, with a statistically significant difference (P<0.001).
Keywords: Adaptation, Psychological, Clinical Trial, Phase I, Questionnaires