Homeopathy for Depression - DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study

A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 × 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode) by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history.For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an attempt to deal with the challenges of homeopathic research and the results might be useful information in the current discussion about the evidence on homeopathyClinicalTrials.gov: NCT01178255From 120 million people that suffer from depression around the world, less than 25% receive adequate treatment [1]. The estimated global burden of disease from major depression, measured as "disability adjusted life years" (DALY), is rising globally, making depression the leading cause of DALYs in middle and high income countries [2]. The overall prevalence of depressive disorders in five European countries was 8.56%, with a higher prevalence in urban Ireland (12.3%) and urban United Kingdom (UK, 17.1%) [3]. The prevalence can be higher in some age groups. For instance, in Berlin, Germany, the prevalence of lifetime depression in 2008 was almost 20% for women between 18 and 29 years old, 25% for women between 40 and 59 years old and, among men, 12% and 15% f