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

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.

Eligibility

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

Conditions2

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