Depression, Bipolar
Conditions
Brief 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.
Interventions
DRUGAbilify 2, 5, 10, 15mg (Tablet)
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.
DRUGPlacebo of Abilify 2, 5, 10, 15mg (Tablet)
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.
Sponsors
Korea Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in the Montgomery-Åsberg Depression Rating Scale total score | Week 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in the Clinical Global Impression-BP version Severity of Illness (Depression) score | Week 8 | The score ranges from 1 to 7. Higher score indicates more severe depression. |
| 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 | Week 8 | The score ranges from 1 to 7. Higher score indicates more severe depression. |
Countries
South Korea
Contacts
Primary ContactHoyoung Lee
Outcome results
None listed