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The SPD489-323 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant.

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The SPD489-323 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2021

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At a glance

  • Drugs Lisdexamfetamine (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Shire

    • Most Recent Events

    • 06 Feb 2014 Top-line results reported in a Shire media release.
    • 06 Feb 2014 Primary endpoint 'Significant superiority of lisdexamfetamine vs placebo in change in score on the Montgomery-Asberg-Depression-Rating-Scale' has not been met, according to a Shire media release.
    • 01 Dec 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.

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