Abstract

Background How to define clinical significance of antidepressants has become a matter of far-reaching clinical and regulatory consequences. A mean difference of at least 3 points on the Hamilton Depression Rating Scale (HAMD-17) between active treatment and placebo has been proposed as cut-off score for clinical significance in antidepressant trials.

Objective We aimed to present arguments that this, and other commonly used related approaches to establish clinical significance are likely to be misleading and risky depriving patients with mild depression of efficient treatments.

Methods These problems are exemplified with the data from a randomized placebo-controlled five-arm clinical trial with primary care patients with milder depressive syndromes (MIND-study).