NCT00216723

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Schizophrenia
• Bipolar Disorder

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2004-04-01
• Completion: 2009-12-01
• First posted: 2005-09-22
• Last updated: 2013-10-23

Locations

2 sites across 1 country: South Korea