About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Abilify 2, 5, 10, 15mg (Tablet)
- Placebo of Abilify 2, 5, 10, 15mg (Tablet)