The European Medicines Agency has published a guideline on clinical investigation of medicines for the treatment of depression. This guideline is a revision of a previous version, which came into operation in October 2002. It went through a six-month public consultation before being adopted by the Agency’s Committee for Medicinal Products for Human Use (CHMP).
This guideline focuses on antidepressants under development specifically for major depressive disorder (MDD). While many treatment options are available for patients with MDD, there is a need for medicines with a better efficacy profile, including a faster onset of action, higher rates of response and remission, and an improved safety profile. Up to a third of patients with MDD only respond partially to treatment and up to 20% are considered treatment-resistant. The revised guideline addresses the specific issues related to these patients and provides recommendations on how to investigate medicines in these two patient populations.
The revision clarifies the requirements for long-term efficacy data and advises on the most appropriate study designs to obtain them. It outlines the fact that the randomised withdrawal study is the design of choice to show maintenance of effect during an episode of depression. The revised guideline also provides more guidance on the requirements for clinical trials in children and adolescents. The document stipulates that complete extrapolation of adult efficacy and safety data is not considered appropriate. As the clinical characteristics may vary between children and adolescents, separate studies are recommended. The revised guideline also provides specific recommendations with regards to clinical evaluation in the elderly.
This guideline will come into effect on 1 December 2013.