Actively Recruiting
A Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aripiprazole as an Add-on Treatment for Major Depressive Episodes in Bipolar I or II Disorder
Led by Korea Otsuka Pharmaceutical Co., Ltd. · Updated on 2024-08-19
390
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of aripiprazole as an additional treatment alongside mood stabilizers in patients with bipolar I or II disorder who are experiencing a major depressive episode without psychotic features. This Phase 3 study targets patients who have not improved adequately despite treatment with lithium or valproic acid for at least 28 days during their current depressive episode. The trial is randomized, double blind, placebo controlled, and multicenter, aiming to provide clear evidence about this combined treatment approach. Participants will be randomly assigned to receive either aripiprazole or a placebo tablet once daily for 8 weeks, while continuing their mood stabilizer treatment. The starting dose of aripiprazole is 2 mg daily, which can be adjusted between 2 and 15 mg based on the participant's response and tolerance at scheduled visits. This dosing flexibility allows the investigators to tailor treatment throughout the 8-week period. During the study, participants will undergo regular assessments including the Montgomery-Åsberg Depression Rating Scale to measure changes in depression severity. Other evaluations include the Clinical Global Impression for Bipolar Disorder and response and remission rates at week 8. Safety and tolerability will be monitored closely, and the study duration for each participant is 8 weeks. This design helps researchers understand how adding aripiprazole affects depressive symptoms in bipolar disorder patients who have not fully responded to mood stabilizers alone.
CONDITIONS
Brief 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 19 to less than 70 years at the time of informed consent
- Patients able to understand information required for giving consent
- Patients currently treated with a mood stabilizer such as lithium or valproic acid
- Patients diagnosed with bipolar I or II disorder with a major depressive episode
- Montgomery-Åsberg Depression Rating Scale total score of 20 or higher at screening and baseline visits
You will not qualify if you...
- Patients diagnosed with bipolar I or II disorder who have mania, mixed episodes, or psychotic features
- Patients considered at high risk of suicide during the study based on current psychotic symptoms or medical history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take aripiprazole or placebo tablets orally once daily from the baseline visit to Week 8, with dose adjustments based on clinical response and tolerability.
7 visits (in-person) from baseline to Week 8
Trial Site Locations
Total: 1 location
1
Seounl National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
Hoyoung Lee
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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