2.1. Design
anxiety disorder, depressive, psychiatric, depression, depressive disorders
DISEASES, POLAND
The Pro-demet pilot trial described herein is an internal feasibility and pilot study included as part of the research design of a larger main study. It was designed as a single-center, parallel-group, prospective, randomized, double-blind, placebo-controlled pilot trial. It took place at the Medical University of Lodz (Poland).Adult patients (≥18 years) with depressive disorders (as defined by 11th International Classification of Diseases [The study population finally consisted of 60 patients recruited in psychiatric outpatient clinics in central Poland and through advertisements in social media. Regarding the sample size, the study was designed to be large enough to provide sufficient information on the chosen feasibility outcome measures [A primary inclusion criterion was a diagnosis of depressive disorders, e.g., depressive episode, recurrent depression, mixed depressive and anxiety disorder [The study timeline has been previously described in detail [