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Efficacy and safety of tianeptine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder. A 8-week, randomized, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study with escitalopram as active control, followed by an optional double-blind extension treatment period of 16 weeks.

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Efficacy and safety of tianeptine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder. A 8-week, randomized, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study with escitalopram as active control, followed by an optional double-blind extension treatment period of 16 weeks.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jul 2018

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At a glance

  • Drugs Tianeptine (Primary) ; Escitalopram
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors IRIS; Servier

    • Most Recent Events

    • 03 Jul 2018 Primary endpoint has been met. (HAM-D 17 total score), as reported in an article published in the Journal of Clinical Psychiatry.
    • 03 Jul 2018 Results published in the Journal of Clinical Psychiatry
    • 02 Mar 2016 Status changed from recruiting to completed, according to European Clinical Trials Database record.

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