Efficacy and safety of agomelatine with flexible dose ( 25 mg/day with blinded adjustment at 50 mg) given orally for 8 weeks in Indian outpatients with Major Depressive Disorder A randomised double-blind national multicentric study with parallel groups, versus sertraline ( 50 mg/day with blinded potential adjustment at 100 mg).

Trial Profile

Efficacy and safety of agomelatine with flexible dose ( 25 mg/day with blinded adjustment at 50 mg) given orally for 8 weeks in Indian outpatients with Major Depressive Disorder A randomised double-blind national multicentric study with parallel groups, versus sertraline ( 50 mg/day with blinded potential adjustment at 100 mg).

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2016

At a glance

  • Drugs Agomelatine (Primary) ; Sertraline
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Serdia Pharmaceuticals
  • Most Recent Events

    • 30 Aug 2016 Last checked against Clinical Trials Registry - India.
    • 22 Feb 2013 Status changed from recruiting to completed as reported by Clinical Trials Registry - India.
    • 29 Jan 2011 Status changed from not yet recruiting to recruiting as reported by Clinical Trials Registry - India
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