A Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents

Trial Profile

A Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents

Completed
Phase of Trial: Phase III

Latest Information Update: 02 May 2016

At a glance

  • Drugs Ziprasidone (Primary)
  • Indications Bipolar disorders; Bipolar I disorders; Lipid metabolism disorders
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors Pfizer
  • Most Recent Events

    • 27 May 2010 Pharmacodynamic outcomes were reported at the 163rd Annual Meeting of the American Psychiatric Association.
    • 26 Jan 2010 Results were published in the Journal of Clinical Psychiatry.
    • 22 Dec 2009 Actual patient number changed 239 to 584 as reported by ClinicalTrials.gov.
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