title: [What place for placebo in clinical trials conducted on psychiatric patients?]
abstract: Placebo effect remains a crucial issue in current clinical trials. Most clinical trials rely on the hypothesis of equivalent placebo response rates in both placebo and specific drug arms ("additive model"). But contrary to this dominant and rarely questioned hypothesis, several aspects may influence placebo response. A few recent meta-analyses and reviews have shown evidence for several clinical and methodological factors, which are able to modulate placebo response. In psychiatry research, placebo response has been mainly explored through antidepressant trials. In early clinical trials, drug-placebo differences were initially significant and robust. However, more recent clinical trials have not yielded similar results, and rather show narrowed antidepressant-placebo differences. Several factors may be involved in this absence of comparability: intrinsic properties of new antidepressants, changes in clinical criteria and classifications, symptomatic remission rather than global remission criteria, industrial and institutional constraints. Moreover, results from antidepressant trials (laboratory conditions) remain hardly fully transposable to clinical routine (ecological conditions).
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France. Electronic address: michel.cermolacce@ap-hm.fr.
authors.forename: M
authors.initials: M
authors.lastname: Cermolacce
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.
authors.forename: R
authors.initials: R
authors.lastname: Belzeaux
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.
authors.forename: M
authors.initials: M
authors.lastname: Adida
authors.affiliation: Service d'explorations fonctionnelles du système nerveux, Clinique du sommeil, CHU de Bordeaux, Place Amélie Raba-Léon, 33076 Bordeaux, France.
authors.forename: J-A
authors.initials: JA
authors.lastname: Micoulaud Franchi
authors.affiliation: Service de Psychiatrie Adultes, CHU Saint Etienne, 5 chemin de la Marendière, 42055 Saint-Etienne Cedex, France.
authors.forename: E
authors.initials: E
authors.lastname: Fakra
authors.affiliation: SHU Psychiatrie Adultes, Hôpital Sainte Marguerite, 13274 Marseille Cedex 9, France.
authors.forename: J-M
authors.initials: JM
authors.lastname: Azorin
mesh_terms: D000928:Antidepressive Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards; D003865:Major Depressive Disorder / Q000188:drug therapy; D017753:Ecosystem; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy*; D015990:Placebo Effect; D010919:Placebos; D012107:Research Design / Q000592:standards
chemical_list: D000928:Antidepressive Agents; D010919:Placebos
keywords: Antidepressants; Antidépresseurs; Clinical trials; Essais cliniques; Placebo