title: Efficacy, tolerability and safety of tianeptine in special populations of depressive patients.
abstract: BACKGROUND
  Tianeptine, a new generation antidepressant, possesses a unique mechanism of antidepressive action and has a specific pharmacokinetic profile. The aim of this study was to determine the efficacy, tolerability and safety of tianeptine in a "fragile" population of depressive patients: (1) a group of elderly patients and (2) a group with comorbid alcohol addiction.
  
  
  METHODS
  This was an open multicentric eight-week study of tianeptine efficacy, tolerability and safety including patients with mild to moderate depression (DSM-IV), age > or =55 years (group 1; n=45) or with comorbid alcohol addiction (group 2; n=32). Assessments was made with the following rating scales; MADRS, HAM-A and CGI for efficacy and DESS for tolerability.
  
  
  RESULTS
  After eight-week tianeptine therapy, remission (MADRS < or =12) was established in 51.1% and 84.4% patients, respectively. On day 7, the therapy led to a significant decrease of MADRS. On endpoint, there were significant differences on HAM-A, CGI-I and CGI-S scores (p<0.01). No adverse effects with frequency > or = 10%, were registered. A lower tolerability of tianeptine was registered in a group of elderly (nausea 4.5%, leg fatigue 4.4%, irritability 2.2%, bursts of crying and sadness 2.2%), while only 3.1% depressive patients with comorbid alcohol addiction had dizziness.
  
  
  CONCLUSIONS
  This is the first clinical study to evaluate tolerability, efficacy and safety of tianeptine in a special population of depressive patients in the region. The study showed that tianeptine had good efficacy in treatment of mild to moderate forms of depression in special populations of depressive patients (elderly population and patients with comorbid alcohol addiction). The drug was well tolerated.
authors: Institute of Psychiatry, Clinical Centre of Serbia, 11000 Belgrade, Pasterova 2, Serbia. olivukovic@gmail.com
authors: Olivera
authors: O
authors: Vuković
authors: Nadja P
authors: NP
authors: Marić
authors: Dubravka
authors: D
authors: Britvić
authors: Tijana
authors: T
authors: Cvetić
authors: Aleksandar
authors: A
authors: Damjanović
authors: Milica
authors: M
authors: Prostran
authors: Miroslava
authors: M
authors: Jasović-Gasić
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000437:Alcoholism / Q000175:diagnosis / Q000523:psychology / Q000534:rehabilitation*; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D003866:Depressive Disorder / Q000175:diagnosis / Q000523:psychology / Q000534:rehabilitation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010555:Personality Inventory; D013841:Thiazepines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000929:Antidepressive Agents, Tricyclic; D013841:Thiazepines; C050504:tianeptine