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

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

Completed

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center, Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aripiprazole

Drug

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)

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start: 2004
Study completion: 2009
First posted: Sep 22, 2005
Registry last updated: Oct 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed