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

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ClinicalTrials.gov Identifier: NCT00216723
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 23, 2013
Sponsor:
Information provided by:
Korea Otsuka Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment
Schizophrenia Bipolar Disorder Drug: Aripiprazole

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.


Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar Disorder
Study Start Date : April 2004
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Patient with a schizophrenia or schizoaffective disorder or bipolar disorder according to DSM-IV criteria
  • Age: more than 18 years of age
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216723


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Jieun Kwon Korea Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Seo Bo Yeon, Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00216723     History of Changes
Other Study ID Numbers: Korea Abilify PMS
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013

Keywords provided by Korea Otsuka Pharmaceutical Co., Ltd.:
Aripiprazole
Schizophrenia
Bipolar Disorder

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs