Study to Test Abilify Aripiprazole Added to Mood Stabilizers for Treating Major Depression in Bipolar I or II Disorder

What this Trial Is About

Researchers are evaluating the effectiveness and safety of aripiprazole as an additional treatment alongside mood stabilizers in patients with bipolar I or II disorder who are experiencing a major depressive episode without psychotic features. This Phase 3 study targets patients who have not improved adequately despite treatment with lithium or valproic acid for at least 28 days during their current depressive episode. The trial is randomized, double blind, placebo controlled, and multicenter, aiming to provide clear evidence about this combined treatment approach. Participants will be randomly assigned to receive either aripiprazole or a placebo tablet once daily for 8 weeks, while continuing their mood stabilizer treatment. The starting dose of aripiprazole is 2 mg daily, which can be adjusted between 2 and 15 mg based on the participants response and tolerance at scheduled visits. This dosing flexibility allows the investigators to tailor treatment throughout the 8-week period. During the study, participants will undergo regular assessments including the Montgomery-sberg Depression Rating Scale to measure changes in depression severity. Other evaluations include the Clinical Global Impression for Bipolar Disorder and response and remission rates at week 8. Safety and tolerability will be monitored closely, and the study duration for each participant is 8 weeks. This design helps researchers understand how adding aripiprazole affects depressive symptoms in bipolar disorder patients who have not fully responded to mood stabilizers alone.

A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression