The clinical significance of antidepressant treatment effects cannot be derived from placebo-verum response differences.
A placebo-verum difference in antidepressant response of at least three points on the Hamilton Depression Rating Scale has been proposed as the threshold for clinical significance in antidepressant trials. Given the considerable clinical and regulatory consequences of such a definition of clinical relevance it deserves a critical discussion. Eight arguments are presented indicating that using this definition as a criterion for assessing the clinical utility of antidepressants in daily practice would risk erroneously discarding treatments with a clear benefit for patients.
Hegerl
U
U
Department of Psychiatry, University of Leipzig, Leipzig, Germany. ulrich.hegerl@medizin.uni-leipzig.de
Mergl
R
R
D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003863:Depression / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D019317:Evidence-Based Medicine; D006801:Humans; D015990:Placebo Effect; D011237:Predictive Value of Tests; D011569:Psychiatric Status Rating Scales; D016032:Randomized Controlled Trials as Topic; D009626:Terminology as Topic; D016896:Treatment Outcome
D000928:Antidepressive Agents