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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Schizophrenia Bipolar Disorder

Keywords

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Aripiprazole Schizophrenia Bipolar Disorder

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Korea Otsuka Pharmaceutical Co.,Ltd.

Principal Investigators

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Jieun Kwon

Role: STUDY_DIRECTOR

Korea Otsuka Pharmaceutical Co., Ltd.

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center