A commentary on the use of depression rating scales in clinical trials conducted in India

Abstract 

India representing over a sixth of the world's population is a popular venue for clinical trials, including those of psychotropic agents. In this commentary, we have focused on the rating scales employed to assess major depressive disorder, especially the Hamilton Depression Rating Scale (HAM-D) and the Montgomery–Asberg Depression Rating Scale (MADRS) in the Indian clinical setting. The prominence given to somatic symptoms in the HAM-D scale may be appropriate for the less “westernized” Indian patients who do not speak English fluently, while the MADRS with more emphasis on cognitive symptoms may be better suited for the urban and westernized Indian subjects. Research into the prevalence of “persecutory ideation” or “fearful mood” or “decreased interest in religious activity” should be undertaken to determine if some of the individual items enquired in these scales require change and/or modification. Finally, even though these are observer rated scales, translations into various Indian languages will likely result in improved quality and validity of clinical trials of major depressive disorder conducted in India. This commentary may be relevant to other non-English speaking populations as well.

Keywords: Depression rating scales, Antidepressant drugs, Clinical trials, India