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.
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
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
Parallel
Abilify 2, 5, 10, 15mg (Tablet)
DrugRandomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.
Placebo of Abilify 2, 5, 10, 15mg (Tablet)
DrugRandomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.
Mean change in the Montgomery-Åsberg Depression Rating Scale total score
Mean change in the MADRS total score from baseline to the end of the study(Week 8) The total score ranges from 0 to 60. Higher score indicates more severe depression.
Mean change in the Clinical Global Impression-BP version Severity of Illness (Depression) score
The score ranges from 1 to 7. Higher score indicates more severe depression.
Response rate
Remission rate
Percentage of subjects with Clinical Global Impression-BP version Severity of Illness (Depression) score of 1 or 2
The score ranges from 1 to 7. Higher score indicates more severe depression.
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