Actively Recruiting
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
Led by Korea Otsuka Pharmaceutical Co., Ltd. · Updated on 2024-08-19
390
Participants Needed
1
Research Sites
405 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 69 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-�c5sberg Depression Rating Scale (MADRS) total score 69 20 at both the screening and baseline visits
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seounl National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
Hoyoung Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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