Conditions: Bipolar I Disorder
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 99
Healthy volunteers: no

Brief summary:
To investigate the safety and efficacy of long-term administration of aripiprazole by performing extended administration of the treatment administered in 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") in a double-blind manner to those patients who complete Study 003 and demonstrate drug efficacy.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Aripiprazole intervention 2: placebo
Intervention descriptions: intervention 1: oral, 24mg(4 tablets)/day intervention 2: oral, 0mg(4tablets)/day

Protocol document: