NCT00216723

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

First QC Date

September 14, 2005

Last Update Submit

October 22, 2013

Conditions

SchizophreniaBipolar Disorder

Keywords

AripiprazoleSchizophreniaBipolar Disorder

Interventions

AripiprazoleDRUG

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)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Patient with a schizophrenia or schizoaffective disorder or bipolar disorder according to DSM-IV criteria
  • Age: more than 18 years of age

You may not qualify if:

  • Unqualified patients judged by study investigator(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

SchizophreniaBipolar Disorder

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jieun Kwon

    Korea Otsuka Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

April 1, 2004

Study Completion

December 1, 2009

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

KR(2)