Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder
Information source: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Bipolar Disorder
Intervention: Aripiprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Korea Otsuka Pharmaceutical Co.,Ltd. Official(s) and/or principal investigator(s): Jieun Kwon, Study Director, Affiliation: Korea Otsuka Pharmaceutical Co.,Ltd.
Summary
This is a multicenter,open-label,prospective study of Aripiprazole use in patients with
schizophrenia and bipolar disorder.
Clinical Details
Official title: Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder
Study design: Observational Model: Ecologic or Community, Time Perspective: Prospective
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Asan Medical Center, Seoul, Korea, Republic of
Samsung Medical Center, Seoul, Korea, Republic of
Additional Information
Starting date: April 2004
Last updated: October 22, 2013
|