Randomized controlled trials of antidepressants: clinically and scientifically irrelevant

Abstract

This contribution to the “antidepressant debate” focuses on the validity of randomized controlled trials (RCTs). We argue that: (a) made-up psychiatric diagnostic categories destroy the purpose and logic of the RCT as a medical experiment, (b) RCTs do everything possible to methodologically stamp out high placebo response rates rather than reveal their clinical implications, (c) assessing a psychoactive drug’s effects greatly exceeds the RCT’s purpose, requiring substantial investigation on normal volunteers, and (d) adverse drug reactions remain understudied, under-recognized, and underappreciated, in parallel with the muting of subjects’ voice and the reliance on surrogate measures of efficacy. The standard psychopharmacotherapy RCT has lost virtually all clinical and scientific relevance, and needs complete revamping. The backdrop for the discussion is American biopsychiatry’s insistence that personal difficulties must be viewed as the expression of idiopathic somatic diseases and the pharmaceutical industry’s dominance of the entire drug treatment research enterprise.