Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00216723
Enrollment
3000
Registered
2005-09-22
Start date
2004-04-30
Completion date
2009-12-31
Last updated
2013-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Schizophrenia

Keywords

Aripiprazole, Schizophrenia, Bipolar Disorder

Brief 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.

Interventions

DRUGAripiprazole

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

Korea Otsuka Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026