A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy.

Trial Profile

A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy.

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Apr 2016

At a glance

  • Drugs Dexmecamylamine (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms RENAISSANCE-5
  • Sponsors AstraZeneca
  • Most Recent Events

    • 07 Apr 2012 Additional trial locations (Croatia and Peru) identified as reported by EudraCT.
    • 20 Mar 2012 Primary endpoint 'Montgomery-Asberg-Depression-Rating-Scale' has not been met, as reported in an AstraZeneca and Targacept media release.
    • 09 Mar 2012 Actual patient number is 696 according to ClinicalTrials.gov.
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