Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder
Completed
- Conditions
- SchizophreniaBipolar Disorder
- Registration Number
- NCT00216723
- Lead Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
This is a multicenter,open-label,prospective study of Aripiprazole use in patients with schizophrenia and bipolar disorder.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3000
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of