Eligibility of schizophrenia inpatients to participate in clinical trials

Abstract Introduction This study assesses the potential eligibility of patients admitted to a psychiatric hospitalisation unit to take part in the major clinical trials based on schizophrenia treatment in clinical practice (CATIE, CUtLASS and EUFEST). Materials and methods A retrospective evaluation by consulting the medical records of 241 subjects (59.8% males and 40.2% females, mean age 39.7 ± 13.0 years), admitted consecutively over one year to psychiatric hospitalisation unit with a diagnosis of schizophrenia or another psychosis. The influence of the factors involved in the non-eligibility in each of the clinical trials is analysed using logistic regression analysis. Results Only 20.7%, 22.3%, and 22.5% of patients with schizophrenia or another psychosis would be eligible to participate in the CATIE, CUtLASS and EUFEST studies, respectively. The main factors involved in the non-eligibility were polytherapy with anti-psychotics (2 or more) (Odds Ratio (OR): 7.64, 95% confidence interval (CI): 3.06–19.06, P P  = .014), and resistance, intolerance or contraindication to any of the anti-psychotics of the study (OR: 3.68, 95% CI: 1.13–11.99, P  = .030). Conclusions Three out of every four patients with schizophrenia or another psychosis admitted to a psychiatric hospitalisation unit are not represented in the major clinical trials on schizophrenia treatment.