Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Bipolar and Related Disorders+3

+ Mental Disorders

+ Bipolar Disorder

From 18 to 80 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Ecologic or Community

Assessing exposures and health outcomes at the community level in order to identify population-wide health trends.
Observational
Study Start: April 2004
See protocol details

Summary

Principal SponsorKorea Otsuka Pharmaceutical Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleEfficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder
NCT00216723
Principal SponsorKorea Otsuka Pharmaceutical Co., Ltd.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Ecologic or Community

These studies look at groups or populations rather than individuals. They explore community-wide exposures and health outcomes to understand public health trends and risks at a broader scale.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bipolar and Related DisordersMental DisordersBipolar DisorderSchizophreniaMood DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Criteria

2 inclusion criteria required to participate
Patient with a schizophrenia or schizoaffective disorder or bipolar disorder according to DSM-IV criteria
Age: more than 18 years of age
1 exclusion criteria prevent from participating
Unqualified patients judged by study investigator(s)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Asan Medical Center

Seoul, South KoreaOpen Asan Medical Center in Google Maps
Suspended

Samsung Medical Center

Seoul, South Korea
Completed2 Study Centers