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

NCT ID: NCT03423680

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-22
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Depression, Bipolar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Abilify (Tablet)

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Randomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.

Placebo of Abilify (Tablet)

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DRUG

Randomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.

Interventions

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

Randomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.

Intervention Type: DRUG

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

Randomized subjects will take 1 tablet of aripiprazole or placebo orally once daily from the baseline visit (Visit 2) to Visit 8 (Week 8 visit or discontinuation visit). The initial dose of aripiprazole, the investigational product, is 2 mg once daily (irrespective of meals), which the investigators can maintain, increase or decrease within a range of 2 - 15 mg at each scheduled study visit, depending on the subject's clinical response and tolerability.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seounl National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hoyoung Lee

Role: CONTACT

hoyounglee@otsuka.co.kr

82-2-3287-9238

Facility Contacts

Yong Min Ahn, MD PhD

Role: primary

Other Identifiers

031-402-00154

Identifier Type: -

Identifier Source: org_study_id