Bipolar I Disorder Clinical Trial
Official title:
A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
To assess the safety and efficacy of long-term administration of aripiprazole by performing extended administration of aripiprazole in combination with mood stabilizer (lithium or valproate) in an unblinded manner to those patients who completed the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter "Study 003") but whose condition worsened or remained unchanged or who discontinued Study 003 between Day 14 and Day 21 due to lack of drug efficacy.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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