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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abilify (Tablet) | Experimental |
| |
| Placebo of Abilify (Tablet) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abilify 2, 5, 10, 15mg (Tablet) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the Montgomery-Ã…sberg 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hoyoung Lee | Contact | 82-2-3287-9238 | hoyounglee@otsuka.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seounl National University Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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|
| Placebo of Abilify 2, 5, 10, 15mg (Tablet) | Drug | 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. |
|
| 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 |