EMA: Guideline on clinical investigation of medicinal products in the treatment of depression

The present document should be considered as general guidance on the development of medicinal products for acute and long-term treatmentof Major Depressive Disorder (MDD). Its main focus is on major depressive episodes that occur in the context of MDD. Despite many approved antidepressants there is still a need for new medicinal products with better efficacy (e.g. faster onset of action, higher rates of response and remission) and improved safety profile in patients with MDD.