Using Abilify to treat bipolar depression
A Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Treatment of Major Depressive Episode Associated With Bipolar I or II Disorder
This study is testing if adding the medication Abilify can help people with bipolar disorder who are having a major depressive episode feel better when their current treatment isn't working.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | Korea Otsuka Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT03423680 on ClinicalTrials.gov |
What this trial studies
This is an 8-week, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of aripiprazole as an adjunctive treatment for patients with bipolar disorder experiencing a major depressive episode. Participants must have been on a mood stabilizer for at least 28 days without sufficient improvement. The study aims to determine if adding aripiprazole can enhance treatment outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 to 70 with bipolar I or II disorder experiencing a major depressive episode and currently on a mood stabilizer.
Not a fit: Patients with bipolar disorder exhibiting manic, mixed, or psychotic features, or those at high risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with bipolar depression who do not respond adequately to mood stabilizers alone.
How similar studies have performed: Other studies have shown promise in using adjunctive treatments for bipolar depression, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Seoul
- Seounl National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Hoyoung Lee
- Email: hoyounglee@otsuka.co.kr
- Phone: 82-2-3287-9238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.