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

Last updated: August 16, 2024
Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Depression

Bipolar Disorder

Mood Disorders

Treatment

Abilify 2, 5, 10, 15mg (Tablet)

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

Clinical Study ID

NCT03423680
031-402-00154
  • Ages 19-70
  • All Genders

Study Summary

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

Inclusion

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 thescreening and baseline visits

Exclusion

Exclusion Criteria:

  • Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropicfeatures

  • Patients considered to have a high risk of suicide during the study period by theinvestigator based on current psychotic symptom and the patient's past medicalhistory

Study Design

Total Participants: 390
Treatment Group(s): 2
Primary Treatment: Abilify 2, 5, 10, 15mg (Tablet)
Phase: 3
Study Start date:
February 22, 2018
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Seounl National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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