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Efficacy and Safety of Aripiprazole

This study has been completed.
Sponsor:
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00216723
First received: September 14, 2005
Last updated: August 10, 2010
Last verified: August 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Schizophrenia
Bipolar Disorder
 Drug: Aripiprazole
 Phase 4

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Post Marketing Surveillance of Efficacy and Safety of Aripiprazole

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Estimated Enrollment: 3000
Study Start Date: April 2004
Study Completion Date: December 2009
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)

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216723

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

No publications provided

Responsible Party: Seo Bo Yeon, Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00216723     History of Changes
Other Study ID Numbers: Korea Abilify PMS
Study First Received: September 14, 2005
Last Updated: August 10, 2010
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Aripiprazole
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013