Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder

Korea Otsuka Pharmaceutical Co., Ltd.3,000 enrolled

Overview

This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder.

This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder. Qualified schizophrenia patients will be enrolled to an 12-week treatment phase of Aripiprazole by physician's assessment. Qualified bipolar disorder patients will be enrolled to an 8-week treatment phase of Aripiprazole by physician's assessment. This study will be continued for 6 years. The final report of Aripiprazole PMS will be submitted to KFDA on December 28, 2009.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Schizophrenia Bipolar Disorder

Interventions

AripiprazoleDRUG

The recommended starting and target dose for Abilify is 10 or 15mg/day administered on a once-a-day schedule without regard to meals. (Administer 10 to 30 mg/day according to the patient's condition)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with a schizophrenia or schizoaffective disorder or bipolar disorder according to DSM-IV criteria * Age: more than 18 years of age Exclusion Criteria: * Unqualified patients judged by study investigator(s)

Locations (2)

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Data from ClinicalTrials.gov

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