Conditions: Bipolar I Disorder
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 59
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: oral, 24mg(4 tablets)/day

Protocol document: