02702nas a2200289   4500000000100000000000100001008004100002260003500043653001200078653001500090653002300105653001500128653002800143100002400171700001500195700001700210700001800227700001800245700002100263245015600284856006700440300001000507490000700517520186100524022001302385020001402398       2020                            d  c12/2020bElsevier Espana S.L.U10aAnxiety10aDepression10aHealthy volunteers10aMotivation10aPhase I clinical trials1 aAndreé Salvatierra1 aIris Lioba1 aMarta Pérez1 aJulian Mateus1 aSantiago Grau1 aAna Aldea-Perona00aHealthy volunteer profile: Levels of anxiety, depression, socioeconomic aspects and candidates  motivations of participation in phase I clinical trials  uhttps://linkinghub.elsevier.com/retrieve/pii/S1134793720300221  a83-900 v263 aIntroduction
Healthy volunteers participate in phase I clinical trials mainly in search of an economic compensation; their economic instability may constitute a vulnerability factor for anxiety/depression.

Objectives
To select suitable and rapid screening tests for anxiety and depression in healthy volunteers, to know their socioeconomic situation and to identify the main reason for their participation.

Methods
Cross-sectional study, under a nonparametric statistical analysis and ROC curve analysis. Goldberg's Anxiety and Depression Scale (GADS) (fast test) and the Beck Depression (BDI-II) and Anxiety (BAI) Inventories (standard tests) were applied to all participants.

Results
One hundred and thirty-nine potential candidates were recruited; the average age was 32 years (SD = 8.8); 53.9% were students, 43.9% employers and 2.2% were unemployed; 85.6% had university studies, 13.7% secondary education and .7% primary studies. GADS, BDI-II and BAI results were: 24.5% volunteered with anxiety and 15.8% with depression (GADS); anxiety levels (BAI): 60.4% had null, 25.9% mild, 11.5% moderate and 2.2% severe; depression (BDI-II): 87.8% had null, 5.8% mild, 5.8% moderate and .7% severe. Socioeconomic characteristics: 48.2% low stratum, 43.2% medium, 5.7% medium high and 2.8% high. Motivations: 46.1% for economic compensation, 35.9% contribution to science, 14.4% for curiosity and 3.6% access to health.

Conclusions
GADS shows insufficient capacity to discriminate between anxiety/depression and the use of BAI and BDI-II is suggested; anxiety and depression levels were higher in healthy volunteers than the prevalence in the general population but lower when compared to university population; employment status was mostly composed of university students with low socioeconomic characteristics and a high economic motivation.  a11347937  a2174-0437