ABLE: Abilify in Bipolar Disorder for Long-term Effectiveness

Summary

To compare combination treatment of aripiprazole plus valproate versus valproate alone in the prevention of relapse in bipolar I disorder patients with symptomatic remission after 5-6 weeks open-label acute treatment with aripiprazole plus valproate for manic or mixed episode, with or without psychotic features.

Conditions

• Bipolar Disorder

Interventions

DRUG

aripiprazole

15-30 mg/day aripiprazole, 22 weeks

DRUG

valproate

sufficient dose as determined by investigator to maintain the therapeutic level.

DRUG

placebo

placebo to aripiprazole, 22 weeks

Sponsors & Collaborators

• Korea Otsuka International Asia Arab

  lead INDUSTRY

Principal Investigators

• Nan-Ying Chiu, MD · Changhua Christian Hospital, Taiwan

• Hun-Yu Chang, MD · Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan

• Yen-Kung Yang, MD · National Cheng-Kung University Hospital

• Wen-Chen Ouyang, MD · Jia-Nan Mental Hospital

• Wei-Wen Lin, MD · Tri-Service General Hospital

• Tso-Ren Wang, MD · Tsao-Tun Psychistric Center

• Efren Reyes, MD · National Center for Mental Health (NCMH)

• Rosanna de Guzman, MD · Philippine General Hospital (PGH)

• Gabino Ranoa, MD · University of Sto. Tomas Hospital (USTH)

• Amadeo Alinea · Veterans Medical Memorial Center (VMMC)

• .Vasu Chantarasak, MD · Somdej Chaophraya Hospital

• Suttiporn Janenawasin, MD · Siriraj Hospital

• F K Tsang, MD · Castle Peak Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-31

Primary Completion

2011-11-30

Completion

2012-11-30

Countries

• Hong Kong
• Philippines
• Taiwan
• Thailand

Study Locations