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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

Page last updated: August 20, 2015

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