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: 24 Aug 2016

At a glance

  • Drugs Dexmecamylamine (Primary)
  • Indications Major depressive disorder
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms RENAISSANCE-4
  • Most Recent Events

    • 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 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 09 Mar 2012 Actual end date (January 2012) added as reported by ClinicalTrials.gov.
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