title: Subgroup analysis of the non-interventional study VIVALDI: agomelatine in treatment-naïve patients, in combination therapy and after treatment switch.
abstract: OBJECTIVE
  Agomelatine has demonstrated antidepressant efficacy in randomized, controlled trials. This non-interventional study VIVALDI evaluated agomelatine treatment under practice conditions.
  
  
  METHODS
  Psychiatrists documented the treatment of 3,317 patients over 12 weeks. According to the treatment condition three subgroups were selected: Agomelatine in treatment-naïve patients as mono-therapy (A), in pretreated patients as add-on-therapy (B), and in pretreated patients switched to agomelatine (C). Effect on depressive symptoms was evaluated via svMADRS and CGI. Daytime functioning and sleep-wake rhythm were assessed by a patient-questionnaire.
  
  
  RESULTS
  The svMADRS decreased from values > 30 at baseline to 12.8 (total population), 10.3 (A), 15.1 (B), and 13.5 (C). 76.1%, 55.7%, and 62.5% of patients were responders in subgroups A, B, and C, respectively, 65.8% in the total population. Remission was achieved in 66.5% (A), 44.7% (B), and 50.9% (C) of patients. After 12 weeks, subjective sleep quality and daytime functioning improved in the majority of patients. Adverse drug reactions (ADR/serious ADR) were reported for 6.0%/0% (A), 11.0%/0.2% (B), and 12.6%/0.3% (C) of patients. Overall, 25.8% of patients discontinued treatment prematurely, 5.2% due to ADR.
  
  
  CONCLUSIONS
  Agomelatine improved depressive symptoms, daytime functioning, and sleep-wake rhythm, and demonstrated good tolerability also in pretreated patients and combination therapy under routine practice.
authors: Kbo-Inn-Salzach-Klinikum, Hospital of Psychiatry, Psychotherapy, Psychosomatic Medicine and Neurology , Wasserburg am Inn , Germany.
authors: Gerd
authors: G
authors: Laux
authors: Nadja A
authors: NA
authors: Huttner
mesh_terms: D000081:Acetamides / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000928:Antidepressive Agents / Q000627:therapeutic use; D002940:Circadian Rhythm / Q000187:drug effects*; D003863:Depression / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; 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
keywords: Agomelatine; circadian rhythms; combination therapy; depression; non-interventional study; treatment switch