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NCT00216723 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00216723
Other study ID # Korea Abilify PMS
Secondary ID
Status Completed
Phase Phase 4
First received September 14, 2005
Last updated October 22, 2013
Start date April 2004
Est. completion date December 2009

Study information
Verified date October 2013
Source Korea Otsuka Pharmaceutical Co.,Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 3000
Est. completion date December 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Aripiprazole
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)

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Korea Otsuka Pharmaceutical Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

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