An assessment of the understanding and motivations of patients with schizophrenia about participating in a clinical trial.

Enrollment of an adequate number of subjects for a clinical trial is a perennial challenge and this might arguably be even more difficult and complex in trials involving patients with schizophrenia. In this paper, we used a modification of the Prospective Preference Approach (PPA) as a prelude to an actual randomized placebo-controlled trial of a cognitive-enhancing agent for patients with schizophrenia. This approach sought to test and enhance subjects' understanding of the key concepts of the trial, and administered the PPA at baseline and following a brief educational module. The motivations and concerns regarding potential participation in the proposed trial were also elicited by the PPA. Of one hundred ninety patients with schizophrenia recruited for this PPA study, only 12 (6.3%) were assessed to have understood all key trial-related concepts after the initial explanation and baseline PPA administration (prior to the educational module). Following the education module, however, there was significant increase in the number of patients who understood all key trial elements. Younger age and higher level of education were significant factors associated with better understanding of the proposed trial. The main reasons cited for wishing to participate in clinical trials were personal medical benefits and altruistic desire to help others. Concerns regarding the safety of the trial medication were expressed in over 80% of the subjects. PPA administration with educational module supplementation may provide a valuable addition to clinical trial procedures in patients with schizophrenia.