title: Early effect on general interest, and short-term antidepressant efficacy and safety of agomelatine (25-50mg/day) and escitalopram (10-20mg/day) in outpatients with Major Depressive Disorder. A 12-week randomised double-blind comparative study.
abstract: A double-blind, randomized, study was conducted in 29 centers in Romania to evaluate the effect of agomelatine 25-50mg/day (n=144 patients) on general interest, overall clinical efficacy, and functionality in comparison with escitalopram 10-20mg/day (n=143 patients) in out-patients diagnosed with moderate to severe Major Depressive Disorder (MDD).
  
  
  
  The primary endpoint of the study was the score difference between agomelatine and escitalopram were assessed on the item 13 of the Quick Inventory of Depressive Symptomatology (16-Item) Self-Report (QIDS-SR16) over the first week period. Secondary measures include the primary criterion on the 12-week period, the within-group evolution over 12 weeks of the 17-item Hamilton Depression Scale (HAM-D17) total score, CGI severity of illness (CGI-S) and CGI-I scores, and functionality by using the self-rated Sheehan Disability Scale (SDS).
  
  
  
  After one week, the mean General Interest score showed no statistically significant difference between treatments. Over 12 weeks, patients felt more and more interested in other people and activities than before having taken medication. Both agomelatine and escitalopram improved depressive symptoms and symptom-related functional impairment of patients. Both agomelatine and escitalopram were well-tolerated by patients.
  
  
  
  The strength of our results would benefit from additional data from trials using a similar design and other active comparators.
  
  
  
  There was no difference in week 1 changes of interest between agomelatine and escitalopram. The relatively good tolerability of agomelatine and escitalopram is confirmed.
authors.affiliation: Clinic No 1, Spitalul Clinic de Neuropsihiatrie Craiova Aleea Potelu, 24-200317 Craiova, Romania. Electronic address: clinicaltrials@psycv.ro.
authors.forename: T
authors.initials: T
authors.lastname: Udristoiu
authors.affiliation: Spitalul Clinic Judeţean de Urgenţă Timişoara 21, Iancu Văcărescu Street Timişoara, Romania. Electronic address: lianadeh@upcmail.ro.
authors.forename: P
authors.initials: P
authors.lastname: Dehelean
authors.affiliation: Hôpital Saint Antoine, Service de Psychiatrie, 184 Rue du Faubourg Saint Antoine, 75012 Paris, France; UMR 7203, Biomolecules Laboratory, Université Pierre et Marie Curie-Paris 6, France. Electronic address: nuss.philippe@gmail.com.
authors.forename: Ph
authors.initials: P
authors.lastname: Nuss
authors.affiliation: Institut de Recherches Internationales Servier (IRIS), 50 Rue Carnot, 92284 Suresnes Cedex, France. Electronic address: rabvanness@gmail.com.
authors.forename: V
authors.initials: V
authors.lastname: Raba
authors.affiliation: Institut de Recherches Internationales Servier (IRIS), 50 Rue Carnot, 92284 Suresnes Cedex, France. Electronic address: francoise.picarel@servier.com.
authors.forename: F
authors.initials: F
authors.lastname: Picarel-Blanchot
authors.affiliation: Institut de Recherches Internationales Servier (IRIS), 50 Rue Carnot, 92284 Suresnes Cedex, France. Electronic address: christian.debodinat@servier.com.
authors.forename: C
authors.initials: C
authors.lastname: de Bodinat
mesh_terms: D000081:Acetamides / Q000627:therapeutic use*; D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D015283:Citalopram / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D011569:Psychiatric Status Rating Scales; D012383:Romania; D012720:Severity of Illness Index; D016896:Treatment Outcome; D009281:Naphthalenes
chemical_list: D000081:Acetamides; D000928:Antidepressive Agents; D015283:Citalopram; D006993:Hypnotics and Sedatives; C084711:agomelatine; D009281:Naphthalenes
keywords: Agomelatine; Antidepressant; Escitalopram; General interest; Outpatients