A Mulitcentre, Double-blind, Randomised, Fixed-dose Evaluation of the Safety and Efficacy of Lamictal (Lamotrigine) Compared to Placebo as an add-on Therapy to Lithium or Another Mood Stabiliser in the Treatment of Bipolar Depression, Followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Patients With Bipolar Disorder

Trial Profile

A Mulitcentre, Double-blind, Randomised, Fixed-dose Evaluation of the Safety and Efficacy of Lamictal (Lamotrigine) Compared to Placebo as an add-on Therapy to Lithium or Another Mood Stabiliser in the Treatment of Bipolar Depression, Followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Patients With Bipolar Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jun 2017

At a glance

  • Drugs Lamotrigine (Primary) ; Paroxetine
  • Indications Bipolar disorders; Bipolar I disorders; Bipolar II disorders
  • Focus Therapeutic Use
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 05 Feb 2010 Results published in Acta Psychiatrica Scandinavica.
    • 01 Feb 2009 Primary endpoint 'Montgomery Asberg Depression Rating Scale' has been met.
    • 15 Oct 2008 Actual start date changed from Jun 2002 to Aug 2002 as reported by Clinicaltrials.gov.
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