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

PHASE3RecruitingINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

February 22, 2018

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

Conditions
Depression, Bipolar
Interventions
DRUG

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.

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.

Trial Locations (1)

Unknown

RECRUITING

Seounl National University Hospital, Seoul

All Listed Sponsors
lead

Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY