A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Depression, Bipolar
In brief
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.
Key facts
- Study ID
- NCT03423680
- Run by
- Korea Otsuka Pharmaceutical Co., Ltd.
- People needed
- 390
- Starts
- 2018-02-22
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-08-19
Who can join
Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Seounl National University Hospital — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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