A multi-centre, double-blind, randomised, parallel-group, placebo-controlled phase III study of the efficacy and safety of quetiapine fumarate sustained release (Seroquel SRTM) in combination with an antidepressant in the treatment of patients with major depressive disorder with inadequate response to an antidepressant treatment

Trial Profile

A multi-centre, double-blind, randomised, parallel-group, placebo-controlled phase III study of the efficacy and safety of quetiapine fumarate sustained release (Seroquel SRTM) in combination with an antidepressant in the treatment of patients with major depressive disorder with inadequate response to an antidepressant treatment

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Aug 2016

At a glance

  • Drugs Quetiapine (Primary)
  • Indications Depression; Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms ONYX
  • Sponsors AstraZeneca
  • Most Recent Events

    • 22 May 2010 Results from a pooled analysis with the PEARL trial [see trial profile 24355] were presented at the 163rd Annual Meeting of the American Psychiatric Association.
    • 04 Dec 2009 The FDA approval of SEROQUEL for add-on treatment of Major Depressive Disorder was based on a supplemental new drug application (sNDA) comprising findings from this and another phase III trial (see trial profile 700024355).
    • 01 Apr 2009 Results published in the Journal of Clinical Psychiatry.
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