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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Treatment of Major Depressive Episode Associated With Bipolar I or II Disorder

Conditions
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Depression, Bipolar

Intervention / Treatment
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* Drug: Abilify 2, 5, 10, 15mg (Tablet)
* Drug: Placebo of Abilify 2, 5, 10, 15mg (Tablet)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abilify (Tablet)<br> | Drug: Abilify 2, 5, 10, 15mg (Tablet)<br>* Randomized 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.<br>|
| Placebo Comparator: Placebo of Abilify (Tablet)<br> | Drug: Placebo of Abilify 2, 5, 10, 15mg (Tablet)<br>* Randomized 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 8 | 
| Response rate |  | Week 8 | 
| Remission rate |  | Week 8 | 
| 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. | Week 8 |