A Study of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Bipolar Depression

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-70
SponsorKorea Otsuka Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Abilify 2, 5, 10, 15mg (Tablet)
  • Placebo of Abilify 2, 5, 10, 15mg (Tablet)

Treatment groups

390 Participants
are divided into 2 treatment groups