A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated with Valproate or Lithium and in Need of Further Clinical Improvement. Revised Protocol 02, Incorporating Administrative Letters 01 and 02 and Amendment 02 (v2.0, dated 17-oct-2008).

Trial Profile

A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated with Valproate or Lithium and in Need of Further Clinical Improvement. Revised Protocol 02, Incorporating Administrative Letters 01 and 02 and Amendment 02 (v2.0, dated 17-oct-2008).

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2013

At a glance

  • Drugs Aripiprazole (Primary)
  • Indications Bipolar I disorders
  • Focus Therapeutic Use
  • Sponsors Bristol-Myers Squibb; Otsuka Pharmaceutical Development & Commercialization
  • Most Recent Events

    • 28 Mar 2012 Official Title amended as reported by European Clinical Trials Database record.
    • 28 Mar 2012 This trial is recruiting in France, Spain, and Italy as reported by European Clinical Trials Database record.
    • 10 Mar 2012 Planned number of patients changed from 388 to 485 as reported by European Clinical Trials Database record.
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