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

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features.

This study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
• Treatments: Aripiprazole

Criteria

Inclusion Criteria:

• Patients aged ≥ 19 and < 70 years at the time of informed consent

• Patients who are able to understand information required for providing a consent

• Patients who have received a mood stabilizer (lithium or valproic acid)

• Patients with bipolar I or II disorder accompanied by major depressive episode

• Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 20 at both the screening and baseline visits

Exclusion Criteria:

• Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropic features

• Patients considered to have a high risk of suicide during the study period by the investigator based on current psychotic symptom and the patient's past medical history