Efficacy and safety of agomelatine with flexible dose (25 mg/day with potential adjustment at 50 mg) given orally for 8 weeks in out-patients with Major Depressive Disorder. A randomised flexible dose double-blind international multicentric study with parallel groups, versus fluoxetine (20 mg/day with potential adjustment at 40 mg).

Trial Profile

Efficacy and safety of agomelatine with flexible dose (25 mg/day with potential adjustment at 50 mg) given orally for 8 weeks in out-patients with Major Depressive Disorder. A randomised flexible dose double-blind international multicentric study with parallel groups, versus fluoxetine (20 mg/day with potential adjustment at 40 mg).

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Apr 2016

At a glance

  • Drugs Agomelatine (Primary) ; Fluoxetine (Primary)
  • Indications Major depressive disorder
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 21 May 2012 Actual end date (21 Jul 2008) added as reported by Chinese Clinical Trial Register.
    • 16 Nov 2011 New trial record
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