A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant.

Trial Profile

A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant.

Discontinued
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2018

At a glance

  • Drugs Lisdexamfetamine (Primary)
  • Indications Major depressive disorder
  • Focus Adverse reactions
  • Sponsors Shire
  • Most Recent Events

    • 16 Jun 2018 Results published in the Journal of Clinical Psychopharmacology
    • 05 Mar 2014 According to the ClinicalTrials.gov record, status changed from recruiting to discontinued as SPD489 failed to demonstrate a benefit as adjunctive treatment to antidepressants
    • 16 Feb 2014 New source identified and integrated (UK Clinical Trials Register; UKCRN-12349).
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