EMA: Draft guideline on clinical investigation of medicinal products in the treatment of schizophrenia
The main requirements for medicinal products developed for the treatment of schizophrenia, with regard to study design, patient population and outcome measures are described. Specific issues, including treatment resistant patient population and other specific patient groups (children and adolescents) are addressed. Attention is focused on alternative treatment options such as add-on and augmentation therapy. The importance of specific domains in schizophrenia including cognition and negative symptoms are discussed as well.