title: Antidepressant effect in older depressed patients: the lessons of two agomelatine trials.
abstract: The present paper reports in parallel the findings of the two phase III trials that evaluated the efficacy of agomelatine in older depressed patients. It describes how the particular methodological innovations (particularly in relation to patient selection, design and accuracy of diagnosis of depression) introduced in study 2 have improved the quality of recruitment of patients and the assay sensitivity. Study 1 lacked assay sensitivity, and among the many differences with study 2, the inclusion of unexpected mildly ill patients could have inflated the placebo response. The increased demands on investigators in study 2 appear to have reduced the placebo effect and showed a robust benefit of agomelatine. The two agomelatine studies offer the opportunity to discuss hypotheses that have been raised to explain the low level of response of older patients to available antidepressants.
authors.affiliation: aDepartment of Psychiatry and Oxford Health NHS Foundation Trust, Warneford Hospital, University of Oxford, Oxford bRadbourne Unit, Royal Derby Hospital, Derby, UK cService de Psychiatrie Generale, Lille Cedex dParis Diderot University, Paris eInstitut de Recherches Internationales Servier (IRIS), Suresnes Cedex, France fUniversity of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Guy M
authors.initials: GM
authors.lastname: Goodwin
authors.forename: Pierre
authors.initials: P
authors.lastname: Thomas
authors.forename: Reinhard
authors.initials: R
authors.lastname: Heun
authors.forename: Patrice
authors.initials: P
authors.lastname: Boyer
authors.forename: Françoise
authors.initials: F
authors.lastname: Picarel-Blanchot
authors.forename: Christian
authors.initials: C
authors.lastname: de Bodinat
mesh_terms: D000081:Acetamides / Q000627:therapeutic use*; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use; D038622:Internationality; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D009281:Naphthalenes
chemical_list: D000081:Acetamides; D000928:Antidepressive Agents; D006993:Hypnotics and Sedatives; C084711:agomelatine; D009281:Naphthalenes