A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
- Conditions
- Depression, Bipolar
- Interventions
- Drug: Placebo of Abilify 2, 5, 10, 15mg (Tablet)
- Registration Number
- NCT03423680
- Lead Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 390
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abilify (Tablet) Abilify 2, 5, 10, 15mg (Tablet) - Placebo of Abilify (Tablet) Placebo of Abilify 2, 5, 10, 15mg (Tablet) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Response rate Week 8 Remission rate Week 8 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.
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.
Trial Locations
- Locations (1)
Seounl National University Hospital
🇰🇷Seoul, Korea, Republic of