Status:
RECRUITING
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Depression, Bipolar
Eligibility:
All Genders
19-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT03423680
Start Date
February 22 2018
End Date
December 1 2025
Last Update
August 19 2024
Active Locations (1)
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1
Seounl National University Hospital
Seoul, South Korea